Concordancia entre las listas de medicamentos esenciales y las guías para diabetes en América Latina y el Caribe / Concordance between essential medicines lists and diabetes guidelines in Latin America and the Caribbean / Concordância entre as listas de medicamentos essenciais e diretrizes para diabetes na América Latina e no Caribe

RESUMEN Objetivo. Analizar la existencia y actualización de las listas de medicamentos nacionales (LMN) y guías de práctica clínica (GPC) para el tratamiento de la diabetes en América Latina y el Caribe (ALC). Comparar los fármacos incluidos en las listas y guías de cada país, entre sí y con los de la Organización Mundial de la Salud (OMS). Métodos. Estudio de corte transversal. Se identificaron las LMN y GPC para diabetes en los sitios web de la Organización Panamericana de la Salud y de las autoridades sanitarias nacionales. Se relevaron los fármacos y se analizaron por grupo farmacológico según el cuarto nivel de la nomenclatura ATC. Se utilizó el puntaje F1 para evaluar la proximidad de las LMN con la lista modelo de medicamentos esenciales (LMME) de la OMS. Resultados. Del total de países, 87,2% cuentan con LMN, y 91% con GPC (78% y 45% actualizadas en los últimos 5 años, respectivamente). En comparación con los 6 grupos de hipoglucemiantes de la LMME, las LMN tenían una mediana (rango) de 6 (4-13) y un puntaje F1 de 0,80; esto indica una consonancia adecuada. Las GPC tenían una mediana (rango) de 12 (1-12) hipoglucemiantes frente a los 8 de las guías de la OMS. Las GPC tuvieron una mediana de 15 fármacos más que las respectivas LMN. Conclusiones. Si bien la mayoría de los países de ALC cuentan con LMN y GPC para diabetes, la falta de concordancia entre ellas limita su eficacia. Es necesario alinear los procesos y criterios de elaboración de estas dos herramientas de la política de medicamentos.

ABSTRACT Objective. Conduct an analysis to determine the existence and updating of national essential medicines lists (EMLs) and clinical practice guidelines (CPGs) for the treatment of diabetes in Latin America and the Caribbean (LAC); and compare the medicines included in each country's list and guidelines both with each other and with those of the World Health Organization (WHO). Methods. Cross-sectional study. EMLs and CPGs for diabetes were found on the websites of the Pan American Health Organization and national health authorities. Medicines were noted and analyzed according to pharmacological group, based on the fourth level of nomenclature of the Anatomical Therapeutic Chemical (ATC) classification system. F1 scoring was used to assess the proximity of EMLs to the WHO Model List of Essential Medicines (MLEM). Results. Of the total number of countries, 87.2% have EMLs, and 91% have CPGs (78% and 45% updated in the last five years, respectively). Compared to the six hypoglycemic groups of the MLEM, the EMLs had a median (range) of 6 (4-13) and an F1 score of 0.80; This indicates proper alignment. CPGs had a median (range) of 12 (1-12) hypoglycemic drugs compared to eight in the WHO guidelines. CPGs had a median of 15 more drugs than their respective EMLs. Conclusions. While most LAC countries have EMLs and CPGs for diabetes, the lack of concordance among them limits their effectiveness. It is necessary to align the processes and criteria for the development of these two tools for policymaking on medicines.

RESUMO Objetivos. Analisar a existência e a atualização das listas nacionais de medicamentos (LNMs) e guias de prática clínica (GPCs) para o tratamento do diabetes na América Latina e no Caribe (ALC). Comparar os medicamentos incluídos nas listas e nas diretrizes de cada país entre si e com as da Organização Mundial da Saúde (OMS). Métodos. Estudo transversal. Foram identificadas LMNs e GPCs para o diabetes nos sites da Organização Pan-Americana da Saúde e das autoridades sanitárias nacionais. Os medicamentos foram pesquisados e analisados por grupo farmacológico de acordo com o quarto nível da classificação ATC. A pontuação F1 foi utilizada para avaliar o grau de proximidade das LMNs com a lista-modelo de medicamentos essenciais (LMME) da OMS. Resultados. Do total de países, 87,2% dispõem de uma LNM e 91%, de GPCs (78% e 45%, respectivamente, atualizadas nos últimos 5 anos). Em comparação com os seis grupos de agentes hipoglicemiantes da LMME, as LMNs tinham uma mediana (intervalo) de 6 (4 a 13) e uma pontuação F1 de 0,80, o que indica uma conformidade adequada. As GPCs tinham uma mediana (intervalo) de 12 (1 a 12) agentes hipoglicemiantes, em comparação com 8 nos guias da OMS. As GPCs tinham uma mediana de 15 medicamentos a mais do que as respectivas LNMs. Conclusões. Embora a maioria dos países da América Latina e do Caribe disponha de LNMs e GPCs para o diabetes, a falta de concordância entre elas limita sua eficácia. É necessário alinhar os processos e os critérios de desenvolvimento dessas duas ferramentas da política de medicamentos.

Caracterización de la oferta de medicamentos en la República Argentina / Characterization of the drug supply in Argentina

Resumen Introducción : Conocer las características del mercado farmacéutico permite obtener información sensible para entender la oferta, la demanda y el acceso de la pobla ción a los medicamentos. Con el objetivo de aportar da tos primarios respecto a la comercialización de fármacos en Argentina, se desarrolló la siguiente investigación. Métodos : Se trata de un estudio descriptivo cuanti tativo-cualitativo transversal del mercado farmacéutico argentino, tomando en cuenta 30 años de información oficial aportada por la Agencia Reguladora Nacional (ANMAT). Resultados : Se identificaron 216 laboratorios (182 nacionales) productores/importadores de medicamentos, 53 distribuidores y 479 droguerías (establecimientos de distribución de medicamentos al por mayor). Se detectó una alta concentración de la comercialización, agrupán dose el 90% de la misma, en solo 5 intermediarios. En el país existen actualmente 6670 productos/certificados, cantidad que fluctuó a lo largo de los últimos 30 años. Seis laboratorios son dueños de entre 116 y 208 certifica dos. El 84% de estos productos provienen de laboratorios nacionales, 5002 son monofármacos, mientras que el 83% se comercializa bajo un nombre de fantasía. Las tres principales indicaciones a las que se destina el registro de medicamentos en la Argentina son enfermedades del aparato digestivo, sistema nervioso, e infecciosas; el 58% es comercializado como formulaciones orales. Discusión : el presente trabajo muestra que el mer cado farmacéutico argentino tiene una participación mayoritaria de capitales nacionales, existiendo gran concentración en pocas empresas productoras y distri buidoras. Los productos son mayormente monodrogas comercializadas en forma oral y ofrecidas por su nombre de fantasía.

Abstract Introduction : Knowing the characteristics of the phar maceutical market allows obtaining sensitive informa tion to understand the supply, demand and access of the population to medicines. In order to provide primary data regarding the marketing of drugs in Argentina, the following research was performed. Method : This is a cross-sectional quantitative-quali tative descriptive study of the Argentine pharmaceutical market, taking into account 30 years of official information provided by the National Regulatory Agency (ANMAT). Results : Two hundred and sixteen laboratories (182 national) drug producers/importers, 53 distributors and 479 drugstores (wholesale drug distribution establishments) were identified. A high concentration of market ing was detected, grouping 90% in only 5 intermediaries. There are currently 6670 products/certificates in the country, an amount that fluctuated over the last 30 years. Six laboratories are owners of between 116 and 208 certificates; 84% of these products come from na tional laboratories, 5002 are mono-drugs, while 83% are marketed under a fancy name. The three main indica tions for which the registration of drugs in Argentina is intended are diseases of digestive system, nervous system and infectious diseases; 58% of the marketed products consist of oral formulations. Discussion : Based on data provided by this study, it is possible to assert that the Argentinian pharmaceutical market has a majority share of national capital, with a great concentration in a few pharmaceutical companies and distributors. The products are mostly available as non-combined drugs, in their oral form, and available by their brand names.

A qualitative and quantitative comparison of adverse drug reaction data of anti-epileptic drugs in various sources of drug information

Background: It is essential to spread awareness about known adverse drug reactions (ADRs) for identification, prevention and their proper management. The aim of this study is to assess disparities in documented ADRS of antiepileptic drugs in various sources of drug information.Methods: An observational, cross sectional study was done to compare different drug information sources for ADRs. Six sources of information namely: National Formulary India (2011), Drug Today (2018), Current index of medical specialties (CIMS), and some textbooks like Lippincott’s illustrated reviews: Pharmacology (2012), Brenner and Stevens' Pharmacology (2018) and George and Goodman and Gilman's (GG): The pharmacological basis of therapeutics (2018) were critically analysed for ADRs of a total of 34 drugs. Prototype drugs and most commonly prescribed antiepileptic drugs, were chosen for study. They were categorized according to therapeutic classification and guidelines by Indian Society of Epilepsy. ADRs were categorized according to various body systems, and serious and life threatening ADRs, then were tabulated and compared. Qualitative and quantitative analysis of this data was also done.Results: None of analysed sources mentioned all antiepileptic drugs. GG contained information for maximum number of drugs studied (76.4%) and National Formulary of India gave information for (52.9%) drugs only. There was wide variability among various resources while listing ADRs. CIMS listed maximum number of ADRs (85.5%) while minimum was included in Brenner and Stevens' Pharmacology (13%) for all antiepileptic drugs. The quality of data though limited was relatively better in CIMS, but none of sources studied were found to be complete.Conclusions: No source of information provided complete information about adverse effects of all 34 anti-epileptic drugs. Academicians and policymakers can work towards providing complete ADR information in all sources of information and updating it from time to time. Thus, making drug use safer in patients of epilepsy.

National Survey of Pharmacy and Therapeutic Committee in Saudi Arabia: Evaluation of Drug Formulary and Decision-Making

Objective: Ministry of Health (MOH) hospitals in Saudi Arabia should develop, organize and administer a formulary system that follows the principles to optimize patient care by ensuring access to clinically appropriate, safe and cost-effective medications. This can be achieved through the Pharmacy and Therapeutic Committee’s (PTC) role in the evaluation of hospital’s drug formulary and decision-making. The primary purposes of the PTC are policy development, communication and education and formulary management. Therefore, in this study, we aimed to explore the hospital drug formulary evaluation and decision-making at MOH hospitals in Saudi Arabia. Methods: This is a 4-month cross-sectional national survey of PTC at MOH hospitals in Saudi Arabia. The survey consisted of two parts: the first part collected demographic information and the second part consisted on 93 questions divided into four domains. An electronic survey was distributed to all drug information centers at MOH hospitals and analyzed the evaluation of drug formulary and decision-making through the Survey Monkey system. Results: A total of 50 drug information centers responded to the questionnaire (100%). Restricted drug usage (3.88), new drug entities (3.74), new dosage form (3.6) and new strength (3.6) were the majority of the requests for inclusion in the formulary. A total of 1-3 medications were evaluated monthly by the PTC at 41 (82%) hospitals. Most of the healthcare providers were allowed to request for the addition or deletion of medications: PTC members 38 (76%), attending medical staff 35 (70%), pharmacy staff 10 (20%) and formulary subcommittees 10 (20%). The formal economic analysis of the drug formulary revision was rarely or never conducted at 26 (42%) hospitals. The responsible person for the economic evaluation was drug information pharmacist (21 (42%)), pharmacy department (nonspecific) (17 (34%)) and the pharmacy and medical department (14 (28%)). Conclusion: Evaluation of hospital’s drug formulary and decision-making was not adequate at the majority of the hospitals. Education and training about drug evaluation with an emphasis on cost analysis and impact are mandatory. An electronic addition new medications with close formulary is required with close monitoring for all MOH hospitals in Saudi Arabia.

National Survey of Pharmacy and Therapeutic Committee in Saudi Arabia: Formulary Management System

Objective: Formulary management is an integrated patient care process which enables physicians, pharmacists and other healthcare professionals to work together to promote clinically sound cost-effective medication therapy and positive therapeutic outcomes. Effective use of healthcare resources can minimize overall medical costs, improve patient access to more affordable care and provide an improved quality of life. A formulary not only includes a list of medications and medication-associated products but also includes medication-use policies, important ancillary drug information, decision support tools and organizational guidelines. Therefore, in this study, we aimed to provide the guiding principles for the Formulary Management System at Ministry of Health (MOH) hospitals in Saudi Arabia. Methods: This is a 4-month cross-sectional national survey of Pharmacy and Therapeutic Committee at MOH hospitals in Saudi Arabia. The survey consisted of two parts: the first part collected demographic information and the second part contained 93 questions divided into four domains. The scope, structure and responsibilities, the formulary management system, the evaluation of drug formulary and decision-making and the committee meetings organization and management. The electronic survey was distributed to 50 drug information centers at MOH hospitals. It analyzed the formulary management system at MOH hospitals in Saudi Arabia through Survey Monkey system. Results: A total of 50 drug information centers responded to our questionnaire. The statement with highest score was related to the committee formulary system of medications usage through ensuring the safety of prescribing, distribution, administration and monitoring of medications (3.8); the process for managing drug product shortages (3.76); and the medications are requested for the addition or deletion from the drug formulary (3.68). Most of the hospitals had an open drug formulary (30 (60%)), with remaining responders having closed drug formulary (20 (40%)) with the total number of medications in the drug formulary (300–899) at 32 (64%) of the responded hospitals. The average score of type of method related to drug usage evaluation statements was 3.36, with the statement with high average score was review of medication error report (3.94) and review of medication sentinel incident reports (3.48), whereas the statement with lowest score was an investigational drug therapy approved (2.88). Conclusion: Two-thirds of the hospitals had open drug formulary. Drug utilization evaluation system should review for the majority of the hospital. update the formulary management system required with close monitoring for all MOH hospitals in Saudi Arabia.

Comparative Study and Reference of Children ’s Edition of WHO ，British and Chinese National Formulary / 中国药房

OBJECTIVE： To provide reference for the revision of China National Formulary for Children and make a sample for Chinese medical institutions to formulate their own formulary. METHODS： The suggestions on formulary revision and the formulation of formulary in medical institutions were put forward through comparing the selection principle， catalogues， chapters， drug items， formulary quantity and coincident drugs of World Health Organization （WHO） Model Formulary for Children （2010 edition） （WMFc）， British National Formulary （Children edition） （2016-2017 edition） （BNFc）， Chinese National Formulary （Children edition） （2013 edition） （CNFc）. RESULTS & CONCLUSIONS： The selection principle of WMFc was safe， effective and economical； that of BNFc was accurate and up-to-date， that of CNFc was safe， effective， economical and appropriate. The catalogues of three formularies included introduction， outline and separated section， but the contents or descriptions were different. For example， in separated section， WMFc was divided into 27 chapters， BNFc was divided into 16 chapters and CNFc was divided into 20 chapters. The chapters and catalogues of WMFc were classified according to ATC； those of BNFc were classified according to organ system and disease arrangement； those of CNFc were classified according to disease treatment system. 15 chapters of three formularies were the same， such as drug for nervous system diseases， drug for endocrine system and drug for respiratory system. The unique chapter of CNFc was “drugs for stomatological diseases”. The drug items of three formularies included drug name， indications， usage and dosage， contraindication， ADR， matters need attention， preparation and specifications， etc. Compared with CNFc， unique chapters of WMFc included ATC numbering， drug interaction， liver injury， etc.； those of BNFc included pharmacological action， interaction， allergy， etc. WMFc contained 271 drugs， CNFc 847 drugs and BNFc 955 drugs. Among them， there were 166 overlaps between WMFc and CNFc， 359 between BNFc and CNFc， 174 between WMFc and BNFc. There were 141 same drugs in the three formularies. When revising or formulating formulary， our country should not copy them mechanically， but should revise formulary according to our national conditions. It is necessary to refer to selection principles of WMFc and BNFc， update our children’s formulary in certain or real time， standardize drug access criteria of formulary， rationally increase the variety of drug and call on the relevant departments of the state to improve the standards for the formulation of drug instructions for children.

Investigation on Labeling and Drug Strategy on Dermatologic Drugs for Pregnant Women / 中国药学杂志

OBJECTIVE: The aim of this study is to investigate labelings on dermatologic drugs for pregnant women and provide qualitative and quantitative pharmaceutical support for clinical use. METHODS: Labelings and formularies on pregnancy of topical drugs were analyzed and sorted according to classification on pregnancy use. Transdermal abilities of the drugs not forbidden nor avoided were evaluated through ACD/LAB 6.0 software and Potts-Guy formulation. Through TOXNET database and dose conversion equation, toxicities on animals were collected and human doses for pregnant women were calculated. RESULTS: In dermatologic drugs, there are 16 drugs forbidden, 8 not recommended/avoided/should not be used, 14 used with caution/weighed pros and cons, 7 used under instruction, 16 unclear or with no statement. In topical drugs not forbidden nor avoided, there are 9 drugs' logKp above-5, butenafine and sertaconazole with strongest transdermal abilities, 7 drugs' logKp influenced under pH5.5 or pH7.0, with a decline in logK'p compared with logKp, still 15 drugs not influenced by pH, 7 drugs' toxicities on animals unknown, 14 drugs' pregnancy human doses under 10 mgkg-1. CONCLUSION: Currently,only a few topical drugs' instructions on pregnancy are clear. With properties and animal experiments, better pharmaceutical support can be provided for clinical use on qualitative or quantitative reference.

Analysis of Global National Drug Policies on Rational Pediatric Drug Use / 中国药房

OBJECTIVE:To evaluate evidence situation and implementation of global national drug policies on rational pediatric drug use,and to provide decision-making reference for setting up national drug policies for rational pediatric drug use which adapt to the situation of China.METHODS:By retrieving domestic and foreign related database,scanning drug management websites of WHO,the European Union as well as many countries and regions.A pre-designed data extraction form was used to collect information of the policies of rational pediatric drug use.The information was summarized and analyzed.RESULTS:A total of 45 literatures were included,involving WHO and the European Union,the United States,Canada,Britain,Ireland,Holland,Germany,Spain,France,Australia,New Zealand,China,India,Korea,Japan,South Africa and many other countries and regions.The main points of concern for the national policies of rational pediatric drug use in all countries included promoting the development of clinical trials of children's drugs,formulating and promoting essential medicine list for children,formulating and promoting standard treatment guideline of national pediatric formulary,etc.,and promoting pediatric drug monitoring after the listing.The United States,the European Union and Japan had enacted national laws and regulations on pediatric drug clinical trials;WHO,South Africa and India had developed pediatric essential medicine list;WHO,Britain and China had established pediatric formulary.CONCLUSIONS:It is suggested that the relevant departments should refer to the experiences of the United States and the European Union and other countries and regions to establish national drug policies which adapt to pediatric disease burden and drug use in China

Chronicles of formulae and set prescriptions in the past dynasties / 中华医学图书情报杂志

Objective To study the distribution of chronicles in formulae and set prescriptions and its reasons ac-cording to their source information.Methods After a standard table of formulae and set prescriptions sources was es-tablished according to the data of documented formulae and set prescriptions, their similarity was sequenced by measuring the edit distance using the string similarity algorithm. After it was checked, the chronicles of formulae and set prescriptions were calculated according to their documented first publication year.Results The emergence and development of formulae and set prescriptions were related with the laws of social stability and wars. The calcu-lated chronicles of formulae and set prescriptions were reliable.Conclusion Sequencing the similarity of formulae and set prescriptions can determine their emergence time, which is thus of great significance for calculating their dosages and may become supplementary method for abstracting information from the formulae and set prescriptions in the past dynasties.

Usefulness of Hospital Formulary and Required Drug Information as a Drug Therapy Reference for Medical Students during Clinical Training / 医薬品情報学

<b>Objective: </b>A hospital Formulary (HF) is useful not only for providing a list of formulary drugs, but also for drug safety management and clinical practice in hospitals.  Our Pharmacy Division serves as a clinical training facility for the Faculty of Medicine and offers a bedside learning (BSL) program that allows students to participate in medical services.  Providing medical students with a requisite understanding of pharmacotherapy in order to effectively provide medical services is the goal of the core curriculum of medical education and HF use in BSL may be effective in achieving this goal.  We conducted a survey in order to examine the usefulness of an HF for medical students during clinical training and to determine what drug information is required by students.<br><b>Methods: </b>Between April 2012 and March 2013, a questionnaire survey was conducted on 88 fifth-year medical students    who participated in a 1-day BSL program using an HF.<br><b>Results: </b>The response rate was 100%.  All students responded that they understood how to use the HF and believed it was useful in BSL.  However, the level of satisfaction with the explanatory notes was significantly lower than that of other sections providing clinically useful additional information such as monographs or supplementary tables (<i>p</i><0.05).  More than 80% of the students considered monographs to be useful for obtaining information on side effects, warnings and contraindications, dosage and administration, indications, dosing in renal impairment, and drug name.  Students generally considered supplementary tables useful for obtaining information on serious side effects and their early identification, points of drug use in renal dysfunction, appropriate drug use in cancer chemotherapy, insulin and diabetes treatment, calculations of pediatric dosing, and a list of clinically used abbreviations.<br><b>Conclusion: </b>These results suggest that medical students believe an HF is useful in BSL.  When medical students participate in pharmacotherapy during BSL programs outside the Pharmacy Division, an HF that not only lists drugs but also contains supplementary tables of clinically useful information may be required.

Uso racional de medicamentos por agentes comunitarios en atención primaria de salud en los ambulatorios rurales del municipio Atures, estado Amazonas, Venezuela, año 2011 / Rational drug use by community workers in primary health care in the rural clinics of the municipality Atures, Amazonas State (Venezuela), year 2011

Venezuela cuenta con los auxiliares de medicina simplificada (AMS) y los agentes comunitarios para la atención primaria en salud (ACAPS), personal no profesional, capacitado para el diagnóstico y tratamiento de enfermedades frecuentes; brindando atención en áreas de difícil acceso y en zonas rurales dispersas. En este trabajo se describió el uso racional de medicamentos por el AMS/ACAPS en los ambulatorios rurales (AR) del municipio Atures, estado Amazonas, Venezuela, en el 2011. Para ello, se realizó un estudio no experimental, de campo, descriptivo, de corte transversal; utilizando los indicadores básicos del uso de medicamentos de la OMS. Se evaluaron 12 de los 16 AR tipo I y el AR tipo II del municipio; registrándose 830 consultas y 1.238 prescripciones de medicamentos durante el segundo trimestre del 2011. El AMS/ACAPS prescribió 1,51 medicamentos por consulta. Del total de las prescripciones, 86,92% se hicieron con su nombre genérico, 11,26% como un medicamento inyectable, 23,88% fueron un antibiótico y solo el 52,51% de las prescripciones estuvieron acordes al primer nivel de atención. De los 13 AR visitados, nueve tenían la lista de medicamentos, cuatro el formulario terapéutico nacional y ocho contaron con otra fuente de información (guías de formación del AMS o ACAPS). La disponibilidad de medicamentos clave tuvo un promedio crítico de 48,72%. La prescripción de medicamentos por el AMS/ACAPS resulta inadecuada debido a que se utiliza una lista de medicamentos que no es acorde para el primer nivel de atención.

Venezuela has simplified medical assistants (AMS) and non-professional community workers for primary health care (ACAPS), trained in the diagnosis and treatment of common diseases; providing care in inaccessible and remote rural areas. In this paper the rational use of drugs by the AMS/ACAPS in rural clinics (AR) of the municipality Atures, Amazonas state (Venezuela) in 2011, was described. For this, a descriptive, non-experimental, field and cross sectional study took place; using the WHO basic indicators of drug use. We evaluated 12 of the 16 type I ARs and the type II AR in the municipality; recording 830 consultations and 1,238 drug prescriptions during the second quarter of 2011. The AMS/ACAPS prescribed 1.51 drugs per consultation. Of all prescriptions, 86.92% were by generic names, 11.26% as an injectable drug, 23.88% were an antibiotic and only 52.51% were in accordance to the primary care level. Of the 13 ARs visited, 9 had the drug list, 4 the national therapeutic formulary and 8 had another source of information (AMS or ACAPS training guides). The availability of key drugs had a critical average of 48.72%. The prescription of drugs by the AMS/ACAPS is inadequate because a list of drugs, which is not according to the first level of care, is used.

Propuesta de guía farmacológica de medicamentos antiinfecciosos esenciales pertenecientes al grupo J01 registrados en la República Bolivariana de Venezuela / Proposed anti drug drug guide core group belonging to J01 registered in the Republic of Venezuela

En la actualidad, el personal de salud que se encarga de la prescripción y dispensación del tratamiento farmacológico a los pacientes y no cuenta con un documento de consulta oficial que abarque únicamente medicamentos de tipo antiinfecciosos cuya elaboración se realice con información aprobada por la Autoridad Reguladora Nacional, el Instituto Nacional de Higiene "Rafael Rangel", ente encargado de evaluar que los medicamentos comercializados en Venezuela cumplan con los requerimientos exigidos de calidad, seguridad y eficacia necesarios para el resguardo de la salud pública. Esta propuesta de Guía Nacional para Medicamentos Antiinfecciosos pertenecientes al Grupo J01, es una recopilación sintética de fichas técnicas-científicas individuales para este tipo de fármacos hasta el primer semestre del año 2014, que se realiza teniendo como base distintos criterios de justificación, tales como: la inclusión de medicamentos comercializados desde 2004, año de última actualización del Formulario Terapéutico Nacional; las altas tasas de morbilidad y mortalidad en Venezuela como consecuencia de enfermedades infecciosas; orientación integral confiable dirigida al personal de salud en cuanto a la prevención, tratamiento, uso racional y eficacia de los medicamentos antiinfecciosos, entre otros.

Currently, the health personnel in charge of prescribing and dispensing of drug treatment to patients and does not have a formal consultation document covering only type of anti-infective drugs whose development is done with information approved by the National Regulatory Authority the National Institute of Hygiene "Rafael Rangel" body responsible for assessing the drugs marketed in Venezuela meet the requirements demanded of quality, safety and efficacy necessary for safeguarding public health. This proposed National Anti-Infective Drugs Guide J01 belonging to the Group, is a synthetic compilation of technical-scientific individual records for such drugs through the first half of 2014, which is done on the basis of justification different criteria, such as: the inclusion of drugs marketed since 2004, last updated National Drug Formulary; high rates of morbidity and mortality in Venezuela as a result of infectious diseases; comprehensive guidance to reliable health personnel about the prevention, treatment, rational use and effectiveness of anti-infective drugs, among others.

Avaliação socioeconômica do tratamento medicamentoso de pacientes geriátricos em ambulatório especializado / Socio-economic evaluation from drug treatment of geriatric patients in specialized clinics

Em estudo realizado com 167 pacientes ambulatoriais idosos atendidos em serviço especializado de geriatria em centro de saúde escola, localizado no bairro da Consolação, no município de São Paulo (SP), foi avaliado o perfil farmacoepidemiológico, investigado se as listas de medicamentos padronizados coincidem com as prescrições e estimados os custos da medicação utilizada. Para este estudo, foram utilizadas informações extraídas dos prontuários médicos e obtidas através de entrevistas com os pacientes ou seus acompanhantes responsáveis. A maioria foi do sexo feminino (74,4%), a média de idade foi 80,4 anos, sendo 71 pacientes entre 60 e 79 anos e 96 entre 80 e 96 anos. Os participantes apresentaram condições socioeconômicas acima da média da população brasileira na faixa etária estudada. O perfil de morbidade, entre os pacientes entrevistados, mostrou média de 6,3 (± 2,5) diagnósticos. O número de medicamentos prescritos a cada paciente foi em média 6,1 (± 2,7). Não houve correlação significativa entre as variáveis pessoais pesquisadas e o número de doenças ou medicamentos registrados. No total foram 1.018 medicamentos prescritos, a maioria (82,9%) de padronizados e distribuídos gratuitamente pelo serviço público. A estimativa de gasto mensal pelo governo com a aquisição desses medicamentos foi de R$ 4.100,55, R$ 24,55/paciente/mês, equivalentes a US$ 11,92/paciente/mês (US$ 0,40/dia). Para 100 pacientes foi registrado pelo menos um medicamento não padronizado, observando-se alguns fármacos indisponíveis na padronização com prevalência relativamente alta de prescrição (memantina, mirtazapina, zolpidem, domperidona). É sugerido um estudo para revisão da padronização de medicamentos para o tratamento de pacientes idosos

In study carried out with 167 elderly outpatients attended in specialized geriatric service in Centro de Saúde Escola, located in Consolação district, in the municipality of São Paulo, was evaluated the pharmacoepidemiological profile, investigating if the standardized medicament lists match with the prescriptions and estimated the costs from the utilized medication. For this study it was used information extracted from the medical handbooks and obtained through interviews with the patients or their accompanying charge. The majority was female (74,4%), average age of 80,4 years old, being 71 patients between 60 and 79 years old, and 96 between 80 and 96 years old. The participants presented socio-economic conditions above the Brazilian average in the age group studied. The morbidity profile, between the interviewed patients, shown an average of 6,3 (± 2,5) diagnostics. The number of medicaments prescribed to each patient had an average of 6,1 (± 2,7). There were no significantly correlation between the personal variables researched and the number of diseases or medicaments registered. In total 1.018 medicaments were prescribed, the majority (82,9 %) of standardized and freely distributed by the public service. The estimative of monthly cost by the government with the acquisition of these medicaments was R$ 4.100,55, R$ 24,55 by patient a month, equivalent to US$ 11,92 a month (US$ 0,40 a day). For 100 patients was registered at least one non standardized medicament, observing some unavailable drugs on the standardization with relatively high prescription prevalence (memantine, mirtazapine, zolpidem, domperidone). It's suggested a revision study from the standardization of medicaments for treatment of elderly patients

Propuesta de manual terapéutico dirigido a los agentes comunitarios de atención primaria en salud (ACAPS) del Municipio Atures del Estado Amazonas. Año 2011 / Proposal for a therapeutic manual aimed at community agents of primary health care (ACAPS) of the Atures Municipality of Amazonas State. Year 2011

El MPPS cuenta con los Agentes Comunitarios para la Atención Primaria en Salud (ACAPS) para la atención de la población en áreas de difícil acceso y zonas rurales dispersas. Para promover el Uso Racional de Medicamentos (URM), está publicada la Lista Básica Nacional de Medicamento Esenciales (LBNME) de uso en el Sistema Público Nacional de Salud a pesar de ello, se refleja una deficiencia en la selección de medicamentos de acuerdo a los niveles de atención, uso inadecuado de antimicrobianos, polimedicación y recetado no acorde con las directrices clínicas. Objetivo General: proponer un Manual Terapéutico dirigido a los ACAPS del Municipio Atures del Estado Amazonas, utilizando como metodología los Indicadores Básicos del Uso de Medicamentos de la OMS. Metodología: se evaluaron 13 ARI ubicados en el Municipio Atures donde labora un ACAPS/AMS, se registraron 830 consultas y 1.238 prescripciones de medicamentos durante el trimestre AbrilJunio del año 2011. Resultados: el ACAPS/AMS utiliza una media de 1,51 medicamentos por consulta, en promedio 86,92% prescribieron un genérico y 11,26% un inyectable, del total de prescripciones 23,88% correspondía a un antibiótico y solo 52,51% de las prescripciones estaban acordes para el Primer Nivel de Atención. Una evaluación complementaria determinó que de 295 prescripciones de antibióticos, 263 (89,15%) no estaban seleccionados para el Primer Nivel de Atención, de la revisión comparativa del Listado de Medicamentos local con la LBNME solo hay coincidencia de un 40%. El 69,23% de los ambulatorios cuentan con una Lista de medicamentos esenciales, el 30,77% disponen de un FTN en comparación a un 61,54% que cuenta con otras fuentes de información. La disponibilidad de medicamentos claves tiene un promedio crítico de 48,72 %. La accesibilidad de información actualizada e imparcial sobre las pautas de tratamientos establecidas para los ACAPS dentro de la APS como la propuesta del Manual Terapéutico, puede favorecer en proporcionar a cada paciente el mejor tratamiento y permitir el uso racional de los recursos disponibles.

MPPS has with Community Agents for Primary Health Care (ACAPS) to the attention of the population in areas of difficult access and remote rural areas. To promote Rational Use of Drugs (RUD), it is published la Lista Básica Nacional de Medicamentos Esenciales (LBNME) for use in the National Public Health System however a deficiency is reflected in the selection of drugs according to levels care, inappropriate use of antimicrobials, polypharmacy and prescribed not in accordance with clinical guidelines. General Objective: To propose a Therapeutic Manual aimed at ACAPS Atures Municipality State of Amazonas, using as a methodology the Core Drug Use Indicators WHO. Methodology: ARI 13 located in the municipality where they work one Atures ACAPS / AMS were evaluated 830 consultations and 1,238 drug prescriptions were recorded during the quarter April-June 2011 year Results: ACAPS / AMS uses an average of 1.51 drugs per encounter on average 86.92% prescribed a generic injectable and 11.26% of the total prescriptions 23.88% corresponded to an antibiotic and only 52.51% of prescriptions were in line for the primary care level. A complementary evaluation found that of 295 antibiotic prescriptions, 263 (89.15%) were not selected for the first level of care, comparative review of the local Drug List with no coincidental LBNME 40%. 69.23% of outpatients have a list of essential drugs, 30.77% have a FTN compared to 61.54% who have other sources of information. The availability of key drugs is a critical average of 48.72%. The accessibility of current and impartial treatment guidelines established for ACAPS within the APS as the proposal of Manual Therapy information can favor in providing each patient the best treatment and allow the rational use of available resources

Selection of Proton Pump Inhibitors (PPIs) for Formulary Inclusion Using an Objective Scoring System in Malaysia.

The main aim of this study was to develop an objective Drug Evaluation Scoring System (DESS) by determining criteria for differentiation among 5 PPI drugs available in the market i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole. Secondly, was to assign weightage according to its importance of the criteria. Thirdly, was to determine the scores and rank the PPI drugs. In developing DESS, 200 points was assigned for the clinical documentation criterion, 300 points for the clinical efficacy criterion, 200 points for the safety criterion and 300 points for the cost criterion. The higher the assigned score, the higher importance the criterion is. The criteria were designed in the format of questionnaire to enable participants to allocate scores according to their perception on the importance of the criteria. Self-administered questionnaires were distributed to 165 specialists and medical officers. Study findings from the scoring system found that all PPI drugs have very negligible difference in clinical efficacy and clinical safety. Omeprazole was found to be the most cost economical PPI in the government hospitals. The DESS was able to compare and rank PPI drugs based on the scoring system and also assist in the selection of PPI drugs into the drug formulary.

Anti-inflammatory Effects of Components in Shuxiong Tablet and Its Possible Formulary Rationality / 中草药·英文版

Objective To determine whether the anti-inflammatory properties of Shuxiong Tablet(SXT)and the effective components group of SXT(ECGS)are equivalent and to assess the formulary rationality.Methods ECGS consisted of Panax notoginsen saponion(PNS),hydroxysafflor yellow A,and ferulic acid plus volatile oil of Ligusticum chuanxiong,which was based on the active ingredients and their ratios in SXT.We compared the anti-inflammatory actions of ECGS and SXT using the xylene-induced edema model and the carrageenan-induced edema model,as well as the analgesic activity of them using the acetic acid-induced writhing model.Moreover,cultured macrophages were incubated with media containing serum isolated from SXT-,ECGS-,or every component of ECGS-treated rats,to compare the depress effects on lipopolysaccharide(LPS)-stimulated NO production and inducible nitric oxide synthase(iNOS)expression.Results ECGS and SXT had equivalent anti-inflammatory actions and analgesic effects at an equipotent dosage in a dose-dependent manner.The drug-containing media could inhibit the LPS-stimulated NO production and iNOS expression in cultured macrophages.A 2 × 2 × 2 ANOVA revealed that three effective components could produce synergistic effect on the inhibition of NO production,and PNS was the capital component.Conclusion ECGS and SXT display an equivalent anti-inflammatory effect,and the formula follows traditional Chinese medicine compatibility principle,which shows obvious formulary rationality.

Cost Awareness and Containment : OPD Pharmaceutical Services of a Speciality Hospital

A major share of the hospital budget gets consumed in maintaining its pharmacy services. The cost consumption pattern of different group of medicines is directly related to the prescription load and prescription pattern. The Medical Officers and specialists of the hospital have got all important role in rational prescription in term of current therapeutics and saving on over prescription. A study carried out in a tertiary level super-speciality hospital indicated that the total cost of medicine per OPD day and cost of antibiotics work out to be Rs. 45291 and Rs. 11974 on an average, respectively. The average cost per prescription of OPD was up to Rs. 123.75.

Overseas Formulary and Formulary System / 中国药房

OBJECTIVE: To provide references Chinese medical institutions about the composing of formulary. METHODS: We reviewed online document and literatures, briefly introduced the concept, structure and contents of formulary as well as the management process of the formulary system in foreign countries. RESULTS & CONCLUSIONS: Formulary can provide effective information in the health-care settings, and the information related to formulary and formulary system abroad serves as a mirror for the composing and enforcing of formulary in China.

Assessment of antibiotics use after introducing a hospital formulary by ATC/DDD methodology.

The objective of this study is to compare the use of antibiotics at the Metropolitan Medical Center Hospital in Jakarta, Indonesia (MMCH), before and after the implementation of a hospital formulary. All antibiotic data under J01 Anatomical Therapeutic Chemical (ATC) classification were collected from pharmacy inpatient and outpatient records. Quantitative antibiotic use was expressed in Defined Daily Doses/100 bed-days (DDDs/hbd) for inpatients and DDDs/1000 patients/day (DDDs/tpd) for outpatients. The general quality of drug use was assessed in number of drugs that account for 90% of the use (DU90%) and the adherence to hospital formulary by substance and brand name within the DU90% segment. Quantitative and qualitative antibiotic use were compared before and after implementation of the formulary (1999 to 2000). The Wilcoxon rank sign test was used to compare overall antibiotic use. Inpatient antibiotic usage decreased significantly by 23.1%, 124.96 DDDs/hbd in 1999 to 96.13 DDDs/hbd during 2000 (p= 0.03) and outpatient antibiotic usage decreased insignificantly by 4.9%, 3.49 DDDs/tpd during 1999 to 3.32 DDDs/tpd during 2000 (p=0.58).The most commonly antibiotic use was ciprofloxacin in inpatient setting during the study and in out-patient setting was amoxicillin in 1999 and ciprofloxacin in 2000. The adherence to the formulary by substance and by brand name in inpatient department was 100% and 90.5% and in outpatient department was 100% and 94.3% during the study. DU 90% by substance name and by brand name was considerably not improved in both settings. The conclusion is that the effectiveness of one year formulary implementation at MMCH was only revealed in inpatient setting.

Focus on the National Essential Drug System / 中国药房

OBJECTIVE:To provide reference for promoting the development of medical and health care in China.METHO-DS:The development process of national essential drug system was reviewed and analyzed and the experience of WHO was drawn on to design the future of national essential drug system in China.RESULTS & CONCLUSION:WHO proposed the concept of national essential drugs and recommended medical institutions to establish drug and therapeutics committee and to prepare "Standard Treatment Guidelines" and "National Formulary" for management of rational use of national essential drug.While essential drug system and basic medical security system have been worked out in China,their impacts of them are not satisfactory because of weak enforcement. "National Essential Drugs List ? The Part for Primary Health Care and Health Institutions" (2009 version) and National Formulary Indicate.The Part of Chemicals and Bidogical Products were published,and they are symbols of the re-beginning of national essential drug system.