Drug therapy problems for patients with tuberculosis and HIV/AIDS at a reference hospital.

OBJECTIVE: To determine the frequency of drug therapy problem in the treatment of patients with tuberculosis and HIV/AIDS. METHODS: Data were obtained through a cross-sectional study conducted between September 2015 and December 2016 at a reference hospital in infectious diseases in Belo Horizonte (MG), Brazil. Sociodemographic, clinical, behavioral and pharmacotherapeutic variables were evaluated through a semi-structured questionnaire. Drug-related problems of pharmaceutical care were classified using the Pharmacotherapy Workup method. Factors associated with indication, effectiveness, safety and compliance drug therapy problem were assessed through multiple logistic regression. RESULTS: We evaluated 81 patients, and 80% presented at least one drug therapy problem, with indication and adherence drug therapy problem being the most frequent. The factors associated with drug therapy problem were age, marital status, new case, ethnicity, time of HIV diagnosis and time to treat tuberculosis. CONCLUSION: The frequency of drug therapy problem in coinfected patients was high and the identification of the main drug therapy problem and associated factors may lead the multiprofessional health team to ensure the use of the most indicated, effective, safe and convenient medicines for the patients clinical condition. Tuberculosis and HIV/AIDS coinfected individuals aged over 40 years are more likely to have drug therapy problems during treatment; in that, the most frequente are those that signal toward need of medication for an untreated health condition and non-compliance to treatment. Thus, older patients, unmarried or married, who have treated tuberculosis before, with a shorter time to tuberculosis treatment and longer time to diagnose HIV/AIDS, should receive special attention and be better followed by a multiprofessional health team because they indicate a higher chance of presenting Problems related to the use of non-adherent drugs.

Current Status of Expiry of Homeopathic Medicines in Brazil, Germany, India and the United States: A Critical Review.

BACKGROUND: Assignment of expiry date to homeopathic medicines is a subject of important concern to its pharmacists and practitioners. This study compares the regulatory framework for the expiry of homeopathic medicines in four countries: Brazil, Germany, India and the United States. FINDINGS: Different or no expiry periods are variously followed. Whereas Germany, with some exceptions, employs a maximum expiry of 5 years for both potencies and finished products, Brazil adopts a 5-year expiry for finished products only, potencies used in manufacture being exempted from an assigned expiry date. In India, all homeopathic medicines except dilutions and back potencies have a maximum of 5 years' shelf-life, including those supplied to consumers. In the United States, homeopathic medicines are exempted from expiry dates. COMMENTS: There is neither a rational basis nor scientific evidence for assigning a short (3-5 years) expiry period for homeopathic medicines as followed in some of the countries, particularly in light of the fact that some studies have shown homeopathic medications to be effective even after 25 years. Homeopathic ultra-dilutions seem to contain non-material activity that is maintained over time and, since these exhibit different chemical properties compared to the original starting material, it is quite possible they possess properties of longer activity than conventional medicines. Regulators should acknowledge this feature and differentiate expiry of homeopathic medicinal products from that of conventional drugs.

Development and content validation of an instrument to document the dispensing of prescribed medicines.

WHAT IS KNOWN AND OBJECTIVE: Qualified dispensing is fundamental for the promotion of the rational use of medicines. Documentation is an indicator of quality and one of the essential steps in the care process. However, in Brazil, there are no models of clinical documentation applicable to dispensing practices. Thus, the objective of this study was to develop and validate an instrument to document the dispensing process of prescribed medicines. METHODS: A methodological development study was carried out from February 2017 to October 2017 in two stages, which were (i) the development of the instrument and (ii) content validation of the proposed instrument. The development phase comprised three stages, which were (i) the elaboration of the prototype based on a previously performed systematic review, (ii) academic brainstorming and (iii) a pre-Delphi consensus. The content validation process was performed using the Delphi technique. The instrument was sent to 40 experts with experience in dispensing, and the consensus among them was calculated using the content validity index (CVI). The study was approved by the Ethics Committee, and all participants signed an informed consent document detailing the terms of the study. RESULTS: In the development stage, three versions of the instrument were generated, which were the prototype, version 1 (changed after academic brainstorming) and version 2 (changed after the pre-Delphi). In the content validation process of version 2 of the instrument, 23 experts returned their evaluation in the first round of the Delphi process and 17 in the second. All the items obtained a CVI >0.83, which resulted in the validation of the instrument. The final instrument comprised the following sections: general information, the identification of technical and legal problems of prescriptions, the conduct for the resolution of the technical and legal problems of prescriptions, medication dispensed, suspected drug-related problems, verbal guidance, written guidance, referral and the referral result. WHAT IS NEW AND CONCLUSION: The developed and validated instrument presents the main variables that should be documented during the dispensing process.

Drug therapy problems for patients with tuberculosis and HIV/AIDS at a reference hospital / Problemas relacionados ao uso de medicamentos em pacientes com tuberculose e HIV/AIDS em hospital referência

ABSTRACT Objective: To determine the frequency of drug therapy problem in the treatment of patients with tuberculosis and HIV/AIDS. Methods: Data were obtained through a cross-sectional study conducted between September 2015 and December 2016 at a reference hospital in infectious diseases in Belo Horizonte (MG), Brazil. Sociodemographic, clinical, behavioral and pharmacotherapeutic variables were evaluated through a semi-structured questionnaire. Drug-related problems of pharmaceutical care were classified using the Pharmacotherapy Workup method. Factors associated with indication, effectiveness, safety and compliance drug therapy problem were assessed through multiple logistic regression. Results: We evaluated 81 patients, and 80% presented at least one drug therapy problem, with indication and adherence drug therapy problem being the most frequent. The factors associated with drug therapy problem were age, marital status, new case, ethnicity, time of HIV diagnosis and time to treat tuberculosis. Conclusion: The frequency of drug therapy problem in coinfected patients was high and the identification of the main drug therapy problem and associated factors may lead the multiprofessional health team to ensure the use of the most indicated, effective, safe and convenient medicines for the patients clinical condition. Tuberculosis and HIV/AIDS coinfected individuals aged over 40 years are more likely to have drug therapy problems during treatment; in that, the most frequente are those that signal toward need of medication for an untreated health condition and non-compliance to treatment. Thus, older patients, unmarried or married, who have treated tuberculosis before, with a shorter time to tuberculosis treatment and longer time to diagnose HIV/AIDS, should receive special attention and be better followed by a multiprofessional health team because they indicate a higher chance of presenting Problems related to the use of non-adherent drugs.

RESUMO Objetivo: Determinar a frequência de problemas relacionados ao uso de medicamentos no tratamento de pacientes com tuberculose e HIV/AIDS. Métodos: Os dados foram obtidos por estudo transversal realizado entre setembro de 2015 e dezembro de 2016 em hospital referência em doenças infectocontagiosas de Belo Horizonte (MG), Brasil. As variáveis sociodemográficas, clínicas, comportamentais e farmacoterapêuticas foram avaliadas por questionário semiestruturado. Classificaram-se os problemas relacionados ao uso de medicamento empregando o método Pharmacotherapy Workup de atenção farmacêutica. Os fatores associados aos problemas relacionados ao uso de medicamentos de indicação, efetividade, segurança e adesão foram avaliados pela regressão logística múltipla. Resultados: Foram avaliados 81 pacientes, e 80% apresentaram pelo menos um problema relacionado ao uso de medicamentos, sendo os mais frequentes ligados à problemas relacionados ao uso de medicamentos de indicação e adesão. Os fatores associados aos problemas relacionados ao uso de medicamentos foram idade, estado civil, caso novo, etnia, tempo de diagnóstico do HIV e tempo de tratamento da tuberculose. Conclusão: A frequência de problemas relacionados ao uso de medicamentos em pacientes coinfectados foi alta, e a identificação dos principais problemas relacionados ao uso de medicamentos e dos fatores associados aos mesmos pode direcionar a equipe multiprofissional de saúde, para garantir o uso dos medicamentos mais indicados, efetivos, seguros e convenientes para a condição clínica dos pacientes. Os indivíduos coinfectados com tuberculose e HIV/AIDS maiores de 40 anos possuem maior chance de apresentarem problemas relacionados ao uso de medicamentos durante o tratamento, sendo os mais frequentes os que indicam a necessidade de medicamento para condição de saúde não tratada e não adesão ao tratamento. Pacientes mais idosos, solteiros ou não, que já trataram a tuberculose antes, com menor tempo de tratamento de tuberculose e maior tempo de diagnóstico de HIV/AIDS devem ter atenção especial no acompanhamento por uma equipe multiprofissional de saúde por indicarem maior chance de apresentar Problemas Relacionados ao uso de Medicamentos de não adesão à terapia.

Medicamentos impróprios para o idoso disponibilizados pelo estado do Rio de Janeiro segundo os critérios de Beers-Fick / Medicamentos inadecuados para el anciano proporcionados por el estado de Río de Janeiro, Brasil según los criterios de Beers-Fick / Inappropriate medications for the elderly provided by the Rio de Janeiro state, Brazil according to the criteria of Beers-Fick

Objective: To check the prevalence of Potentially Inappropriate Medications (MPI) for the elderly among the available ones in primary health care by the State Secretariat of Health of the state of Rio de Janeiro, Brazil. Method: This is a study with secondary data from the State Directory of Medicines (rem) and it is analyzed in the light of the guidelines provided for in respect of according to the Beers-Fick of 2012. Results: It was found that in REM-RJ, out of a total of 124 medicines, 13.70% (n = 17) are considered MPIs to elderly, with consumption in 2 broad categories (that act in the CNS and peripheral = 35.29%; and operating in cardiovascular and renal system = 29.41%). Conclusion: This research highlights the need to develop criteria aligned with the perspective of the brazilian elderly and the adaptation of the Beers-Fick criteria, and the elaboration of specific overviews, you behold reflecting its this population and its peculiarities, considering references scientific significance.

Objetivo: Verificar a prevalência de Medicamentos Potencialmente Inapropriados (MPI) para idosos entre os disponibilizados na atenção primária à saúde pela Secretaria de Estado da Saúde do Estado do Rio de Janeiro. Método: Trata-se de estudo realizado com dados secundários provenientes da Relação Estadual de Medicamentos (REM) e analisados à luz das orientações previstas pela Relação de Beers-Fick de 2012. Resultados: Verificou-se que na REM-RJ, de um total de 124 medicamentos, 13,70% (n = 17) são considerados MPIs para idosos, com consumo em 2 grandes categorias (que atuam no SNC e periférico = 35,29%; e que atuam no sistema cardiovascular e renal = 29,41%). Conclusão: A presente investigação evidencia a necessidade de se desenvolver critérios alinhados à perspectiva do idoso brasileiro, sendo possível a adaptação dos critérios de Beers-Fick, e a elaboração de súmulas específicas que contemplem esta população e suas peculiaridades, considerando referenciais de significância científica.

Objetivo: Demostrar la prevalencia de medicamentos potencialmente inadecuados (MPI) para ancianos entre los disponibles en la atención primaria de salud de la Secretaría de Estado de Salud del estado de Río de Janeiro, Brasil. Método: Este es un estudio desarrollado con datos secundarios de la Relación Estadual de Medicinas (REM) y analizadas a la luz de las listage Beers-Fick de 2012. Resultados: Se encontró en la REM-RJ, de un total de 124 medicamentos, 13,70% (n = 17) se considera mpi para ancianos, con un consumo en 2 categorías (que actúan en el snc y periférico = 35,29%; y de funcionamiento en el sistema cardiovascular y renal = 29.41%). Conclusión: Este estudio resalta la necesidad de desarrollar criterios alineados con la perspectiva del anciano brasileño y la adaptación de los criterios de Beers-Fick, y la elaboración de descripciones específicas, que lleve en cuenta sus particularidades, considerando referenciales de importancia científica.

Curso de superación sobre selección y manejo con antimicrobianos en infecciones respiratorias y urinarias / Post-Graduate Course in Selection and management with antimicrobial in respiratory and urinary infections

Fundamento: los antimicrobianos constituyen uno de los grupos farmacológicos de mayor prescripción y uso en la Atención Primaria de Salud, por su eficacia en el tratamiento de múltiples infecciones. Estudios anteriores muestran que existen dificultades en su prescripción por parte de los médicos de este nivel de atención.Objetivo: diseñar un curso de superación profesional acerca de la selección y manejo adecuados de los antimicrobianos en infecciones respiratorias y urinarias en la atención primaria de salud. Métodos: estudio descriptivo, realizado en la Universidad de Ciencias Médicas de Cienfuegos, conformado por tres etapas: diagnóstico del nivel de conocimientos tomando como muestra 113 médicos de la familia de todas las áreas de salud de la provincia de Cienfuegos; diseño del curso, y validación de este por criterio de expertos. Para el diseño del curso se consideraron las recomendaciones de las guías y protocolos con las mejores evidencias científicas disponibles acerca del tema. Resultados: la mayoría de los encuestados, presentó un nivel de conocimientos entre medio y bajo acerca del tema. El curso fue estructurado en cinco temas, con sus respectivos objetivos, formas organizativas docentes, orientaciones metodológicas, métodos y medios de enseñanza. Los expertos lo validaron y consideraron factible, pertinente y de elevada calidad. Conclusiones: el curso puede contribuir al incremento de los conocimientos de médicos de la familia en cuanto a selección y manejo de antimicrobianos en las infecciones más frecuentes en la Atención Primaria de Salud, y por tanto, a mejorar la calidad de la atención médica al paciente(AU)

Background: one of the pharmacologic groups of bigger prescription and use in Primary Health Attention, for his efficacy in the treatment of multiple infections constitute the antimicrobial. Previous studies evidence that there are difficulties in their prescription by doctors of this level of attention.Objective: designing a post-graduate course about the suitable selection and management of the antimicrobial in respiratory and urinary infections in primary health attention. Methods: a descriptive study, accomplished at the University of Medical Sciences of Cienfuegos, shaped for three stages: diagnosis of the level of knowledge taking as sample 113 comprehensive general doctors of all the health areas of Cienfuegos; the course's design, and its validation by consulting experts. They were considered the recommendations of the guides and protocols with the best available scientific evidences about the theme.Results: the majority of the inquired individuals presented a level of knowledge between middle and low about the theme. The course was structured in five themes, with its respective objectives, organizational teaching forms, methodological guidelines, methods and teaching aids. The experts validated the course and considered it feasible, pertinent and of lofty quality. Conclusions: the course can contribute to the increment of doctors knowledge of the family about a selection and management of antimicrobial in the most frequent infections in Primary Health Attention, and therefore, to upgrade medical attention to the patient(AU)

An analysis of unused and expired medications in Mexican households.

BACKGROUND: Unsafe storage of unused medications at home leads to an increased risk of toxicity, accidental childhood poisoning or risk for suicide, whereas an improper disposal of unwanted/expired medications from household raises concern about environmental pollution. OBJECTIVE: The aim of the study was to characterize expired medications collected according to the types of therapeutic groups, pharmaceutical dosage forms, expiration dates and were prescribed or over the counter drugs, and whether they came from Mexican health system or purchased by patients themselves. SETTING: The study was conducted in the metropolitan area of Monterrey during a 12-month period from March 2012 to February 2013. METHOD: Unused/expired drugs were collected according to the collection and disposal of expired medication program instituted by the Department of Health of the State of Nuevo León. Pharmacists and students from The Autonomous University of Nuevo León recorded types of therapeutic groups, total of medicines in each group, among other classification criteria. MAIN OUTCOME MEASURE: The proportion of every collected therapeutic group, type of dosage forms, and expiration date. RESULTS: The amount of medications classified was 22,140 items corresponding to a 30 % of the total collected medications in that period of time; most of them belonged to the non-steroidal anti-inflammatory drugs (16.11 %). According to the pharmaceutical dosage forms, results showed that a high percentage were solid dosage forms (73.39 %), of the total unused/expired medications, most of them were prescription drugs (91 %) which were purchased at private pharmacies. Expiration date of medications ranges from 1995 to 2016, being 2011 the outstanding year (36.66 %). CONCLUSION: Addressing the aspect of unused drug disposition constitutes a challenge for Mexican government, due to health implications related to inadequate disposition. No matter how efficient the programs of collection and disposal of expired drugs are, none of them can collect all unused or expired drugs, that is the reason why the best approach might be to prevent this need.

Legal suits: pharmaceutical industry strategies to introduce new drugs in the Brazilian public healthcare system.

OBJECTIVE: To assess the distribution rate of legal suits according to drug (manufacturer), prescribing physician, and attorney filing the lawsuit. METHODS: A descriptive study was carried out to assess the lawsuits in the São Paulo State (Southeastern Brazil) courts registry in 2006, and amounts spent in complying with these lawsuits, and total costs with medication thus resulting. RESULTS: In 2006, the São Paulo State Administration spent 65 million Brazilian reais in compliance with court decisions to provide medication to approximately 3,600 individuals. The total cost of the medication was 1.2 billion Brazilian reais. In the period studied, 2,927 lawsuits were examined. These lawsuits were filed by 565 legal professionals, among which 549 were attorneys engaged by private individuals (97.17% of the total legal professionals). The drugs scope of the lawsuits had been prescribed by 878 different physicians. By assessing the number of lawsuits filed per attorney, it was found that 35% of them were brought before the courts by 1% of them. CONCLUSIONS: The data related to the lawsuits and to the medication classified according to manufacturer, show that a small number of attorneys is responsible for the largest number of lawsuits filed to obtain these drugs. The finding that more than 70% of the lawsuits filed for certain drugs are the responsibility of one single attorney, may suggest a close connection between this professional and the manufacturer.

[Adherence to essential medicines in cities from three Brazilian states]. / Adesão a listas de medicamentos essenciais em municípios de três estados brasileiros.

This study compared the Municipal Essential Medicines Lists (REMUME) and examined adherence by prescribers and availability of essential medicines in the health units affiliated with the Unified National Health System (SUS). Data were collected on lists and medicines prescribed to 2,411 patients enrolled consecutively in primary or secondary care services in Brazilian municipalities. Of 5,222 prescribed medicines, 76.4% were present on the REMUME, 76.8% on the National List of Essential Medicines (RENAME), and 63% on the World Health Organization (WHO) list. Among the most frequently prescribed medications, one or more did not belong to the respective REMUME. Of all medicines prescribed, 76.1% were available in the inspected facilities; for essential medicines, the availability increased to 88.1%. Prescription in disagreement with the REMUME may result from the unavailability of medicines in the inspected facilities or the lists' inadequacy for the level of care.

Adesão a listas de medicamentos essenciais em municípios de três estados brasileiros / Adherence to essential medicines in cities from three Brazilian states

Este estudo comparou as Relações Municipais de Medicamentos Essenciais (REMUME), analisou a adesão dos prescritores e a disponibilidade de medicamentos essenciais em unidades de saúde vinculadas ao Sistema Único de Saúde (SUS). Foram coletados dados sobre as REMUME e os medicamentos prescritos a 2.411 pacientes arrolados consecutivamente em oito serviços de atenção primária ou secundária de municípios da região centro-sul do país. A disponibilidade dos medicamentos foi verificada por meio da existência de estoque na farmácia. De um total de 5.222 medicamentos prescritos, 76,4 por cento constavam nas REMUME, 76,8 por cento na Relação Nacional de Medicamentos Essenciais (RENAME) e 63 por cento na lista da Organização Mundial da Saúde (OMS). Entre os medicamentos mais prescritos, um ou mais não pertenciam às respectivas REMUME. Do total de medicamentos prescritos, 76,1 por cento estavam disponíveis nos locais pesquisados; entre os medicamentos essenciais, a disponibilidade aumentou para 88,1 por cento. A prescrição em desacordo com as REMUME pode ser resultado da indisponibilidade dos medicamentos nos locais investigados ou da inadequação das listas frente ao nível de complexidade da atenção.

This study compared the Municipal Essential Medicines Lists (REMUME) and examined adherence by prescribers and availability of essential medicines in the health units affiliated with the Unified National Health System (SUS). Data were collected on lists and medicines prescribed to 2,411 patients enrolled consecutively in primary or secondary care services in Brazilian municipalities. Of 5,222 prescribed medicines, 76.4 percent were present on the REMUME, 76.8 percent on the National List of Essential Medicines (RENAME), and 63 percent on the World Health Organization (WHO) list. Among the most frequently prescribed medications, one or more did not belong to the respective REMUME. Of all medicines prescribed, 76.1 percent were available in the inspected facilities; for essential medicines, the availability increased to 88.1 percent. Prescription in disagreement with the REMUME may result from the unavailability of medicines in the inspected facilities or the lists' inadequacy for the level of care.

[Beer-Fick criteria and generic drugs in Brazil]. / Critérios de Beers-Fick e medicamentos genéricos no Brasil.

BACKGROUND: Determine, according to the Beer-Fick criteria, the prevalence of drugs potentially inappropriate for the elderly available as generic medication in Brazil. METHODS: Analysis of the list of generic medications issued by " Diário Oficial da União" on July/12/2004 and of the page of the National Agency for Sanitary Surveillance (ANVISA) - www.anvisa.gov.br, using the Beers-Fick criteria. RESULTS: From the list of 299 products 20 (6.7% of the total) included in the Beers-Fick criteria were analyzed, mainly in the categories of anxiolytics, platelet antiaggregants, antiallergics, anti-angina and vasodilators, antiarrythmics, antidepressants, antispasmodics, anti-hypertensive's, non steroid antinflammatories, antiulceratives and cardiac glycosides. These criteria do not include drugs such as cough suppressants, cinnarizine, diltiazem, piracetam, quinolones, xanthines, creams, ointments and ophthalmic solutions which are also present in the list of generic medication. CONCLUSION: The Beers-Fick criteria may prevent use of drugs potentially inappropriate for the elderly, however, it should be stressed that these criteria are not complete for Brazilian generic medications.

Critérios de Beers-Fick e medicamentos genéricos no Brasil / Beer-Fick criteria and generic drugs in Brazil

OBJETIVO: Determinar a prevalência de fármacos potencialmente inapropriados para idosos em medicamentos genéricos brasileiros pelos critérios de Beers-Fick. MÉTODOS: Análise da lista de medicamentos genéricos publicada no Diário Oficial da União de 12 de julho de 2004 e copiada da página da Agência Nacional de Vigilância Sanitária (ANVISA) - www.anvisa.gov.br, utilizando-se os critérios de Beers-Fick. RESULTADOS: Contendo 299 produtos e/ou apresentações, a lista analisada apresentava 20 deles (6,7 por cento do total) incluídos nos critérios de Beers-Fick, concentrados nas categorias de ansiolíticos, antiagregantes plaquetários, antialérgicos, antiangionosos e vasodilatadores, antiarrítmicos, antidepressivos, antiespasmódicos, anti-hipertensivos, antiinflamatórios não esteroidais, antiulcerosos e glicosídeos cardíacos. Esses critérios não incluem fármacos como antitussígenos, cinarizina, diltiazem, piracetam, quinolonas, xantinas, cremes, pomadas e colírios que fazem parte dessa lista de medicamentos genéricos. CONCLUSÃO: Critérios de Beers-Fick são úteis para a prevenção do uso de fármacos potencialmente inapropriados em idosos, com a ressalva de que não são completos para medicamentos genéricos brasileiros.

BACKGROUND: Determine, according to the Beer-Fick criteria, the prevalence of drugs potentially inappropriate for the elderly available as generic medication in Brazil. METHODS: Analysis of the list of generic medications issued by " Dißrio Oficial da União" on July/12/2004 and of the page of the National Agency for Sanitary Surveillance (ANVISA) - www.anvisa.gov.br, using the Beers-Fick criteria. RESULTS: From the list of 299 products 20 (6.7 percent of the total) included in the Beers-Fick criteria were analyzed, mainly in the categories of anxiolytics, platelet antiaggregants, antiallergics, anti-angina and vasodilators, antiarrythmics, antidepressants, antispasmodics, anti-hypertensive's, non steroid antinflammatories, antiulceratives and cardiac glycosides. These criteria do not include drugs such as cough suppressants, cinnarizine, diltiazem, piracetam, quinolones, xanthines, creams, ointments and ophthalmic solutions which are also present in the list of generic medication. CONCLUSION: The Beers-Fick criteria may prevent use of drugs potentially inappropriate for the elderly, however, it should be stressed that these criteria are not complete for Brazilian generic medications.