Marco jurídico de la prescripción médica en odontología / Legal framework of medical prescription in odontology

La receta médica es la materialización del acto médico a través de la cual el profesional de la salud prescribe a su paciente los fármacos necesarios para aliviar su enfermedad. Existen numerosas sustancias o fármacos que, por sus efectos, no pueden ser ofrecidas al público en general si no es mediante la expedición de una receta médica; por tanto, existen numerosas legislaciones y normas que regulan la prescripción médica con el objetivo de tener un control sobre los fármacos prescritos. A su vez, la receta médica debe tener una estructura específica, misma que está establecida por numerosas leyes y reglamentos sanitarios y que interesantemente es ignorada por múltiples médicos u odontólogos. El objetivo del presente artículo es definir el concepto de prescripción médica, así como indagar en todas las leyes y normas vigentes que regulan la prescripción médica en México (AU)

The medical prescription is the materialization of the medical act through which the health professional prescribes to his patient the necessary drugs to alleviate his illness There are numerous substances or drugs that, due to their effects, cannot be offered to the general public, except through the issuance of a medical prescription, and therefore, there are numerous laws that regulate the medical prescription with the aim of having control over prescribed drugs. In turn, the medical prescription must have a specific structure, which is established by numerous health laws and regulations, and which, interestingly enough, is ignored by many doctors and dentists. The aim of this article is to define the concept of medical prescription as well as to investigate all the current laws and regulations that regulate the medical prescription in Mexico (AU)

Medication package inserts do not present adequate information on potential risks for older adults in Brazil / Bulas de medicamentos não apresentam informações adequadas sobre potenciais riscos para idosos no Brasil

OBJECTIVE: To compare information on the risks of potentially inappropriate medications (PIMs) for older adults in the Beers criteria with data in the package inserts made available by the Brazilian Health Regulatory Agency. METHODS: This is an observational, cross-sectional study that compared information on the package inserts of 33 brand-name drugs in the Brazilian market with specific recommendations for older adults contemplated in the Beers criteria, categorizing them into: complete, incomplete, absent, or discrepant. RESULTS: Among the analyzed package inserts, 21.21% did not present a specific section dedicated to the use of these drugs by older adults and data were scattered throughout the text; 63.64% were classified as incomplete; 33.33% lacked data; and 3.03% had discrepant information. CONCLUSION: The analyzed package inserts presented incomplete data or lacked information characterizing the drugs as PIMs for older adults. This study demonstrated that some package inserts of drugs used in Brazil are not satisfactory, warranting higher caution in the medical community when prescribing these medications and guiding patients

OBJETIVO: Comparar as informações sobre os riscos de medicamentos potencialmente inapropriados (MPIs) para idosos contidas nos critérios Beers com as informações presentes nas bulas para profissionais de saúde disponibilizadas pela Agência Nacional de Vigilância Sanitária no Brasil. METODOLOGIA: Estudo observacional e transversal que comparou informações das bulas para profissionais de saúde de 33 medicamentos de referência no mercado brasileiro com recomendações específicas para idosos contempladas nos critérios Beers e que foram categorizadas em: completas, incompletas, ausentes ou discrepantes. RESULTADOS: Dentre as bulas dos MPIs analisadas, 21,21% não apresentam seção específica destinada ao uso desses medicamentos por idosos, nas quais as informações estão dispersas pelo texto; 63,64% delas foram classificadas como incompletas; 33,33% tinham informações ausentes; e 3,03% com informações discrepantes. CONCLUSÃO: As bulas analisadas apresentaram dados incompletos ou não apresentam qualquer informação que caracterizasse o medicamento como MPI para idosos. Este estudo demonstra que algumas bulas de medicamentos utilizados no Brasil não estão satisfatórias, sugerindo maior cautela à comunidade médica na prescrição e na orientação aos seus pacientes

Criterios de Beers para identificar el consumo de medicación potencialmente inapropiada: adaptación para su aplicación en Argentina / Beers criteria to identify the consumption of potentially inappropriate medication: adaptation for its application inArgentina

Introducción. Los Criterios de Beers son los más utilizados para evaluar el uso de medicación potencialmente inapropiada en grandes poblaciones, pero no contemplan algunos medicamentos de uso frecuente fuera de los EE.UU. Objetivo. Realizar una adaptación al contexto de Argentina de los Criterios de Beers publicados en 2019. Métodos. Fue elaborada una lista preliminar de medicación potencialmente inapropiada adaptada a la comercialización local, que luego fue consensuada por un panel de expertos (método Delphi). Resultados. De los 112 medicamentos originales listados en la tabla dos de los Criterios de Beers (en forma individual o como grupo), fueron excluidos 36 por no estar disponibles el país y fueron sumados 23 que no se comercializan en los EE.UU. pero sí en Argentina. Luego de dos rondas y de consensuar la suma a esta lista de dos grupos farmacológicos(antimigrañosos y vasodilatadores periféricos), fue acordado el agregado de picosulfato, bisacodilo, senósidos y cáscara sagrada como medicación potencialmente inapropiada en el grupo de agentes contra el estreñimiento, la fluoxetina entre los inhibidores selectivos de la recaptación de serotonina y el Ginkgo biloba como droga contra la demencia. También hubo consenso en advertir el riesgo de hipotensión ortostática asociado a la tamsulosina, en aconsejar la consideración de la carga anticolinérgica total del esquema terapéutico administrado y en recomendar al paracetamol como primera línea de tratamiento del dolor, asociado o no a opioides. Conclusiones. Contar con una versión de los Criterios de Beers 2019 adaptada al contexto de Argentina contribuirá al desarrollo y monitoreo de intervenciones para prevenir y reducir el consumo de medicación potencialmente inapropiada. (AU)

Introduction.The Beers Criteria is the most widely used criteria to assess the use of potentially inappropriate medication in large populations, but they do not include some medications that are frequently used outside the United States. Objective.To make an adaptation of the Beers Criteria published in 2019 to the context of Argentina. Methods. A preliminary list of potentially inappropriate medication adapted to local market and practice was designed, which was then agreed upon by a panel of experts (Delphi method). Results. Of the 112 original drugs in the table 2 of the Beers Criteria (individually or as a group), 36 were excluded because they were not available in Argentina and 23 locally marketed drugs but not in the US were included. After two rounds and agreeing to add two additional pharmacological groups to this list (antimigraine and peripheral vasodilators), it was decided to add picosulfate, bisacodyl, sennosides and cascara sagrada as potentially inappropriate medication in the group of anti-constipation agents, fluoxetine among. the selective serotonin reup take inhibitors and Ginkgo biloba as an anti-dementia drug. There was also consensus in warning about the risk of orthostatic hypotension associated with tamsulosin,in advising consideration of the total anticholinergic load of the therapeutic regimen administered, and in recommending paracetamol as the first line of pain treatment, associated or not with opioids. Conclusions. Having a version of the Beers Criteria 2019 adapted to the Argentine context will contribute to the development and monitoring of interventions to prevent and reduce the consumption of potentially inappropriate medication. (AU)

Potential prescribing omissions according to START criteria at the time of hospital discharge

The purpose of this study is to describe the frequency of potential drug prescribing omissions (PPOs) for elderly patients at the time of hospital discharge and to compare the frequency PPOs among different medical specialities. This cross-sectional study examined data from elderly patients when they were admitted for >24 h to a northeastern Brazil teaching hospital during June-December 2016. Were included in the study 227 patients, of whom 36.9% had at least one PPO. The highest number of PPOs was identified among those with at least 5 prescribed drugs. In total, 153 PPOs were identified at hospital discharge. In most cases (78.4%), patients were not evaluated by the specialist physician.The most commonly identified PPOs on discharge were: the omission of statin therapy in cases of diabetes mellitus plus one or more cardiovascular-associated factor; calcium and vitamin D supplements in patients with known osteoporosis; and angiotensin converting enzyme inhibitors in cases of chronic heart failure. The results of this study suggest that the frequency of prescribing omissions PPOs during patient discharge was high. This can be avoided by the careful evaluation by prescribers with experience in certain specialties where several prescribed omissions would be common.

Medication discrepancies in a hospital in Southern Brazil: the importance of medication reconciliation for patient safety

Medication discrepancies are of great concern in hospitals because they pose risks to patients and increase health care costs. The aim of this study was to estimate the prevalence of inconsistent medication prescriptions to adult patients admitted to a hospital in southern Santa Catarina, Brazil. This was a patient safety study on patients recruited between November 2015 and June 2016. The participants were interviewed and had their medical records reviewed. Discrepant medications were considered those that did not match between the list of medicines taken at home and the prescribed drugs for treatment in a hospital setting. Of the 394 patients included, 98.5% took continuous-use medications at home, with an average of 5.5 medications per patient. Discrepancies totaled 80.2%, The independent variables associated with the discrepancies were systemic arterial hypertension, hypercholesterolemia, vascular disease, number of medications taken at home, and poor documentation of the medications in the medical record. Findings from this study allowed us to conclude there was a high rate of prescription medication misuse. Medication reconciliation is crucial in reducing these errors. Pharmacists can help reduce these medication-related errors and the associated risks and complications.

Problemas en la prescripción de medicamentos en Venezuela / Problems in the prescription of medicines in Venezuela

En años recientes los venezolanos hemos enfrentado problemas de diversa índole con relación a la situación de salud. Entre ellos, problemas en la prescripción y la obtención de medicamentos. En esta publicación se tratarán aspectos importantes para la correcta prescripción y obtención de medicamentos, lo cual, a su vez, debería ser el colofón de la atención médica de primera que siempre ha caracterizado a nuestro país y que hoy, lamentablemente, ha devenido en una situación muy dolorosa. La prescripción y obtención de medicamentos puede verse dificultada por diversos inconvenientes, entre los cuales podemos considerar aquellos que tienen relación con el medicamento propiamente dicho, con el prescriptor y el cliente, con las regulaciones vigentes en nuestro país y con la disponibilidad en los centros autorizados para su venta. Como consecuencia de una prescripción inadecuada y un consumo inapropiado de medicamentos pueden surgir problemas muy serios, entre los cuales habría que destacar, en el campo de los antiinfecciosos, la resistencia bacteriana. Y en el campo de fármacos destinados al tratamiento del dolor, la ansiedad y el insomnio, la posibilidad de adicciones diversas. La prescripción adecuada de medicamentos conlleva la necesidad de conocer, a la par de los efectos beneficiosos y terapéuticos de los mismos, la posibilidad de efectos adversos e interacciones. Todos los prescriptores sanitarios deben conocer los fundamentos de la Farmacovigilancia, la cual permitirá conocer el verdadero balance riesgo-beneficio de los fármacos, por lo cual hacemos una breve mención de la misma al final de esta presentación(AU)

In recent years, Venezuelans have faced various kinds of problems related to the health situation. Among them, problems in prescription and acquisition of medicines. This publication will discuss important aspects for the correct prescription and obtention of medicines, which, in turn, should be the culmination of the excellent medical care that has always characterized our country but that today, unfortunately, has become a very disgraced and sad situation. Prescription and acquisition of medicines can be hindered by various inconveniences, among which we can consider those that are related to the product itself, to the prescriber and the client, to the regulations in force in our country and to the availability in authorized centers for sale. As a result of an inadequate prescription and consumption of medications, very serious problems can arise, among which, in the field of anti-infectives, bacterial resistance should be highlighted. In the field of drugs for the treatment of pain, anxiety and insomnia, the possibility of diverse addictions. Proper prescription of medicaments entails the need to know, along with their beneficial and therapeutic effects, the possibility of adverse effects and interactions. All health prescribers must know the basics of Pharmacovigilance, which allow to know the true risk-benefit balance of drugs, so we make a brief mention of it at the end of this presentation.(AU)

Cambios en las prescripciones y el consumo de antimicrobianos, luego de la implementación de recomendaciones de uso: experiencia en un hospital universitario / Changes in prescriptions and antibiotic consumption after the implementation of recommendations for use: experience in a university hospital

Resumen Introduccion: Actualmente cerca de la mitad de las prescripciones de antimicrobianos son inadecuadas, lo que aumenta la resistencia bacteriana. Tanto cefalosporinas como fluoroquinolonas se asocian con este fenomeno: aumento de bacterias productoras de β-lactamasas e infecciones por Clostridioides difficile, por lo que las agencias reguladoras buscan racionalizar su uso. Objetivo: Evaluar el efecto de recomendaciones para el uso adecuado de antimicrobianos en la proporcion de prescripciones inadecuadas de ceftriaxona y fluoroquinolonas. Metodologia: Se desarrollo un estudio de antes y despues, prospectivo e intervencional, que comparo la calidad y la cantidad de uso de ceftriaxona y fluoroquinolonas antes y despues de la implementacion de recomendaciones de uso para tratamientos de enfermedades infecciosas adquiridas en la comunidad. Los parametros medidos fueron: proporcion de prescripciones inadecuadas y DDD. Los datos se analizaron por medio del test de χ2, correccion de Fisher y test de Student. Resultados: Se evaluaron 206 pacientes, observandose una disminucion de 35% en las prescripciones inadecuadas, una reduccion del consumo de ceftriaxona y levofloxacina y un aumento significativo de la utilizacion de ampicilina/sulbactam. Conclusiones: La implementacion de recomendaciones de uso basadas en evidencia cientifica y susceptibilidad local, permitieron disminuir la proporcion de prescripciones inadecuadas y reducir el consumo de ceftriaxona y fluoroquinolonas.

Background: Nowadays about half of antibiotic prescriptions are inadequate, increasing bacterial resistance. Both cephalosporins and fluoroquinolones are associated with this phenomenon: increase of β-lactamase producing bacteria and Clostridioides difficile infections, which is why regulatory agencies seek to rationalize their use. Aim: To evaluate the effect of use recommendations on the proportion of inadequate prescriptions of ceftriaxone and fluoroquinolones. Methods: A prospective and interventional study was developed, comparing the quality and quantity of use of ceftriaxone and fluoroquinolones before and after the implementation of use recommendations for treatments of infectious diseases acquired at the community. The outcomes were: proportion of inadequate prescriptions and defined daily dose (DDD). Data were analyzed using the Chi-square test, Fisher's correction and Student's test. Results: A total of 206 patients were evaluated, a 35% decrease in inadequate prescriptions, a decline in the consumption of ceftriaxone and levofloxacin, and a significant increase in the use of ampicillin/ sulbactam was observed. Conclusions: The implementation of use recommendations based on scientific evidence and local susceptibility allowed to reduce the proportion of inadequate prescriptions and to reduce de consumption of ceftriaxone and fluoroquinolones.

Análise da confiabilidade de fórmulas para o cálculo de dose de antibacterianos em odontopediatria / Analysis of the reliability of formulas for calculating antibacterial doses in pediatric dentistry

Objetivo: avaliar a confiabilidade de fórmulas para o cálculo da dose dos principais antibacterianos em crianças de diferentes idades e pesos, tendo como padrão-ouro as dosagens fornecidas em bulas. Sujeitos e método: 45 crianças, com idades de 3, 6 e 9 anos, constituíram três grupos independentes. Os dados antropométricos foram obtidos por meio da análise de prontuários da Clínica de Odontologia Infantil da Faculdade Integrada de Pernambuco. As dosagens foram calculadas através das fórmulas estabelecidas a partir de parâmetros de peso, idade e superfície corporal. Os antibacterianos selecionados para a análise foram: Amoxicilina, Amoxicilina com clavulonato de potássio, Clindamicina, Claritromicina, Eritromicina e Azitromicina. Os dados foram submetidos ao teste paramétrico de análise de variância. Para verificar se houve diferença entre as dosagens estabelecidas por fórmulas e a dose estabelecida pela bula (padrão-ouro), foi aplicado o teste post-hoc de Tukey. Os testes estatísticos foram realizados com uma margem de erro de 5%. Resultados: nenhuma fórmula foi válida para todos os antibacterianos quando se comparou com a dose padrão estabelecida em bula. Os resultados apresentaram maiores variabilidades no grupo de crianças com menor idade, podendo ser considerado um risco clínico. Conclusão: as dosagens pediátricas dos antibacterianos obtidas por meio de fórmulas não são confiáveis para os grupos etários analisados e, portanto, não devem ser utilizadas para fins de prescrição medicamentosa. (AU)

Objective: This cross-sectional study evaluated the reliability of formulas for calculating the dose of the main antibacterials in children of different ages and weight, and the gold standard were the dosages provided in package inserts. Subjects and method: Forty-five children aged 3, 6, and 9 years constituted three independent groups. The anthropometric data were obtained through the analysis of medical records of the Child Dentistry Clinic of Faculdade Integrada de Pernambuco, Brazil. The dosages were calculated using the formulas established from parameters of weight, age, and body surface. The antibacterials selected for this analysis were amoxicillin, amoxicillin with potassium clavulanate, clindamycin, clarithromycin, erythromycin, and azithromycin. The data were subjected to parametric analysis of variance. In order to verify whether there was a difference between the dosages established in the formulas and the dose established in the package insert (gold standard), Tukey's post-hoc test was applied. The statistical tests were performed with a 5% margin of error. Results: No formula was valid for all antibacterials when compared to the standard dose established in package inserts. The results showed greater variability in the group of younger children, which may be considered a clinical risk. Conclusion: The pediatric dosages of antibacterials obtained in formulas are not reliable for the age groups analyzed and therefore should not be used for drug prescription purposes. (AU)

The use of mobile educational tools to improve antimicrobial prescription for the treatment of acute pyelonephritis in pregnancy: A retrospective cross-sectional study / O uso de ferramentas educacionais móveis para o aperfeiçoamento da prescrição médica do tratamento de pielonefrite aguda na gestação: estudo transversal retrospectivo

Abstract Objective To analyze the prescription of antimicrobial agents for pregnant women admitted into the obstetrics service who presented with acute pyelonephritis. Methods Three cross-sectional studies were performed comparing the prescription of antimicrobials for pyelonephritis in pregnant women in the time periods evaluated (2010-2011: 99 patients evaluated; 2013: 116 patients evaluated; 2015: 107 patients evaluated), at the Hospital Fêmina, Porto Alegre, in the state of Rio Grande do Sul, Brazil. The analysis was performed before and after the promotion of an institutional protocol for the treatment of pyelonephritis during pregnancy, and on a third occasion after the introduction of a smartphone-based mobile educational tool. Results The evaluation of the prescribing physicians and the adequacy of the prescriptions between the different periods studied revealed a significant increase in appropriate conduct for the choice of antimicrobial (2010: 83.8%; 2013: 95.7%; and 2015: 100%), route of administration (2010: 97%; 2013: 100%; and 2015: 100%), and interval (2010: 91.9%; 2013: 95.7%; and 2015: 100%), following the introduction of the protocol, and again after the implementation of the softwareapplicationwithorientationsontheantimicrobial treatment. Conclusion The use of specific mobile applications should be encouraged to attain a better quality and accuracy in prescriptions and to include strategies that not only reduce the risk of negative outcomes, but also improve the quality of care and treatment for maintaining the health both of the mother and of the baby.

Resumo Objetivo Analisar a prescrição de antimicrobianos para gestantes admitidas no serviço de obstetrícia que apresentaram pielonefrite aguda. Métodos Foram realizados três estudos transversais comparando a prescrição de antimicrobianos para pielonefrite em gestantes nos períodos avaliados (2010-2011: 99 indivíduos avaliados; 2013: 116 indivíduos avaliados; 2015: 107 indivíduos avaliados), no Hospital Fêmina, Porto Alegre, RS, Brasil. A análise foi realizada antes e após a promoção de um protocolo institucional para o tratamento da pielonefrite durante a gravidez e, em uma terceira ocasião, após a introdução de uma ferramenta educacional móvel para uso por smartphone. Resultados A avaliação das prescrições médicas e a adequação das prescrições entre os diferentes períodos estudados revelaram um aumento significativo na conduta adequada para a escolha do antimicrobiano (2010: 83,8%; 2013: 95,7%; e 2015: 100%), via de administração (2010: 97%; 2013: 100%; e 2015: 100%) e intervalo (2010: 91,9%; 2013: 95,7%; e 2015: 100%), após a introdução do protocolo, e novamente após a implementação do aplicativo com orientações sobre tratamento antimicrobiano. Conclusão O uso de aplicativos móveis específicos deve ser incentivado para obter melhor qualidade e precisão nas prescrições e incluir estratégias que não apenas reduzam o risco de resultados negativos, mas que também melhorem a qualidade dos cuidados e do tratamento para manter a saúde conjunta da mãe e do bebê.

Pharmacotherapeutic follow-up in a respiratory intensive care unit: description and analysis of results / Acompanhamento farmacoterapêutico em unidade de terapia intensiva respiratória: descrição e análise de resultados

ABSTRACT Objective: To describe and evaluate the pharmacotherapeutic follow-up by a clinical pharmacist in an intensive care unit. Methods: A descriptive and cross-sectional study carried out from August to October 2016. The data were collected through a form, and pharmacotherapeutic follow-up conducted by a clinical pharmacist at the respiratory intensive care unit of a tertiary hospital. The problems recorded in the prescriptions were quantified, classified and evaluated according to severity; the recommendations made by the pharmacist were analyzed considering the impact on pharmacotherapy. The medications involved in the problems were classified according to the Anatomical Therapeutic Chemical Classification System. Results: Forty-six patients were followed up and 192 pharmacotherapy-related problems were registered. The most prevalent problems were missing information on the prescription (33.16%), and those with minor severity (37.5%). Of the recommendations made to optimize pharmacotherapy, 92.7% were accepted, particularly those on inclusion of infusion time (16.67%), and dose appropriateness (13.02%), with greater impact on toxicity (53.6%). Antimicrobials, in general, for systemic use were drug class most often related to problems in pharmacotherapy (53%). Conclusion: Pharmacotherapeutic follow-up conducted by a pharmacist in a respiratory intensive care unit was able to detect problems in drug therapy and to make clinically relevant recommendations.

RESUMO Objetivo: Descrever e avaliar o acompanhamento farmacoterapêutico do farmacêutico clínico em uma unidade de terapia intensiva. Métodos: Trata-se de um estudo descritivo, com desenho transversal, realizado no período de agosto a outubro de 2016. Os dados foram coletados por meio de um formulário de registro, com acompanhamento farmacoterapêutico realizado pelo farmacêutico clínico na unidade de terapia intensiva respiratória de um hospital terciário. Os problemas registrados nas prescrições foram quantificados e classificados, sendo avaliados quanto à gravidade; as recomendações realizadas pelo farmacêutico clínico foram analisadas em relação ao impacto na farmacoterapia. Os medicamentos envolvidos nos problemas foram categorizados utilizando o Anatomical Therapeutic Chemical Classification System. Resultados: Foram acompanhados 46 pacientes, tendo sido registrados 192 problemas relacionados à farmacoterapia. Os problemas prevalentes foram informação ausente na prescrição (33,16%) e com gravidade menor (37,5%). Das recomendações realizadas para a otimização da farmacoterapia, 92,7% foram aceitas, sendo prevalentes aquelas referentes a inclusão do tempo de infusão (16,67%) e a adequação da dose (13,02%), com maior impacto na toxicidade (53,6%). Os anti-infecciosos gerais para uso sistêmico constituíram classe de medicamentos mais frequente nos problemas relacionados à farmacoterapia (53%). Conclusão: O acompanhamento farmacoterapêutico realizado pelo farmacêutico em uma unidade de terapia intensiva respiratória mostrou-se capaz de detectar problemas na farmacoterapia dos pacientes e realizar recomendações clinicamente relevantes.

Suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups / Adequação às faixas etárias pediátricas de medicamentos novos registrados no Brasil de 2003 a 2013

ABSTRACT Objective To analyze suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups. Methods A descriptive study of drugs with pediatric indication included in a retrospective cohort of new drugs registered in Brazil. The evaluation of drug suitability for the pediatric age group was performed using the following criteria: suitability of dosage form and capacity to deliver the recommended dose. The drugs were considered adequate for the pediatric age groups when they met both criteria. The statistical analysis included calculation of frequencies and proportions. Results Suitability due to the drug capacity to deliver the recommended dose was greater than 80% across all age groups. Regarding suitability of the dosage form, we identified that the older the age group, the greater suitability for pediatric use. Concerning the drugs presented in solid dosage form, we showed that half were classified as inadequate for one or more pediatric age groups to whom they were indicated. The adequacy of drugs to the pediatric age group was 64.3% for preschool children, 66.7% for full-term newborns, 66.7% for premature newborns, and over 70% for other age groups. Conclusion Drugs for children aged under 6 years were less often adequate, considering the dosage form and capacity to provide the recommended dose. The availability and proportional suitability of medicines for pediatric use are greater for older age groups, according to age groups the drug is registered for.

RESUMO Objetivo Analisar a adequação às faixas etárias pediátricas dos medicamentos novos registrados no Brasil no período de 2003 a 2013. Métodos Estudo descritivo dos medicamentos com indicação pediátrica incluídos em uma coorte retrospectiva de medicamentos novos registrados no Brasil. A avaliação da adequação do medicamento à faixa etária pediátrica foi realizada empregando os seguintes critérios: adequação da forma farmacêutica e capacidade de fornecer a dose recomendada. Os medicamentos foram considerados adequados às faixas etárias pediátricas quando preencheram os dois critérios. A análise estatística compreendeu cálculo de frequências e proporções. Resultados A adequação devido à capacidade do medicamento fornecer a dose recomendada foi superior a 80% em todas as faixas etárias. Em relação à adequação da forma farmacêutica, identificou-se que quanto maior a faixa etária, maior a proporção de adequação para uso pediátrico. Em relação aos medicamentos que se apresentavam em formas farmacêuticas sólidas, evidenciou-se que metade foi classificada como inadequada para uma ou mais faixas etárias pediátricas para as quais estavam indicados. A adequação dos medicamentos à faixa etária pediátrica foi 64,3% para pré-escolares, 66,7% para recém-nascidos a termo, 66,7% para recém-nascidos prematuros e superior a 70% para as demais faixas etárias. Conclusão Os medicamentos destinados às crianças menores de 6 anos apresentaram menor frequência de adequação, considerando a forma farmacêutica e a capacidade de fornecer a dose recomendada. A disponibilidade e a proporção de adequação dos medicamentos para uso pediátrico aumentam com a elevação da faixa etária para a qual o medicamento é registrado.

Mobile health application to assist doctors in antibiotic prescription - an approach for antibiotic stewardship

ABSTRACT Background: Technologies applied to mobile devices can be an important strategy in antibiotic stewardship programs. Objective: The aim of this study was to determine the impact of a decision-making application on antibiotic prescription. Methods: This was an observational, analytical and longitudinal study on the implementation of an antimicrobial guide for mobile application. This study analyzed the period of 12 months before and 12 months after the app implementation at a university hospital based on local epidemiology, avoiding high cost drugs and reducing the potential for drug resistance including carbapenem. Antimicrobials consumption was evaluated in Daily Defined Dose/1000 patients-day and direct expenses converted into USD. Results: The monthly average consumption of aminoglycosides and cefepime had a statistically significant increase (p < 0.05), while the consumption of piperacillin/tazobactam and meropenem was significantly decreased (p < 0.05). The sensitivity to meropenem as well as to polymyxin increased after the app implementation. A decrease in sensitivity to cefepime was observed after introduction of this antibiotic as a substitute of piperacillin/tazobactam for treating intra-hospital infections.There was a net saving of USD 296,485.90 (p < 0.05). Conclusion: An antibiotic protocol in the app can help antibiotic stewardship reducing cost, changing the microbiological profile and antimicrobial consumption.

Conformity of nurse prescribing to care needs: nurses' understanding / Conformidad de la prescripción de enfermería a las necesidades de atención: concepción de enfermeros / Conformidade da prescrição de enfermagem às necessidades de cuidados: concepção de enfermeiros

ABSTRACT Objective: investigate the understanding of nurses on nurse prescribing conformity to the care needs of hospitalized patients and factors associated with that conformity. Method: a descriptive study, with a quantitative approach, was conducted at 20 in-patient units of a teaching hospital in the state of São Paulo. The participants (N=139) answered a semi-structured questionnaire. Results: For 43 (30.9%) nurses, nurse prescribing is always in line with patients' care needs. The fields of body care and elimination, skin and mucosa care and investigation and monitoring were the most frequently addressed. Conclusion: in the perception of most nurses, nurse prescribing does not conform with patients' health heeds. The establishment of strategies to improve prescribing quality is recommended, as well as the development of permanent qualification programs and the systematic use of instruments for assessment of patients' care demands regarding nursing.

RESUMEN Objetivo: investigar la concepción de enfermeros sobre conformidad de prescripción de enfermería a necesidades de atención de pacientes hospitalizados y factores asociados a tal conformidad. Método: estudio descriptivo, con abordaje cuantitativo, realizado en 20 unidades de internación de hospital de enseñanza del estado de São Paulo. Los participantes (N=139) completaron cuestionario semiestructurado. Resultados: para 43 (30,9%) enfermeros, las prescripciones de enfermería estuvieron siempre alineadas a las necesidades de cuidado de los pacientes. Las áreas de Cuidado Corporal y Eliminaciones, Cuidado de Piel y Mucosas e Investigación y Monitoreo fueron las más abordadas. Conclusión: según visión de la mayoría de enfermeros, no hay conformidad de prescripción de enfermería con necesidades de atención de los pacientes. Se recomienda implementación de estrategias para mejorar la calidad de las prescripciones, cualquier otro desarrollo de programas de calificación continuada y utilización sistemática de instrumentos de evaluación de demanda de atención del paciente referentes a enfermería.

RESUMO Objetivo: investigar a concepção de enfermeiros sobre a conformidade da prescrição de enfermagem às necessidades de cuidados de pacientes hospitalizados e fatores associados a esta conformidade. Método: estudo descritivo, com abordagem quantitativa, realizado em 20 unidades de internação de um hospital de ensino do estado de São Paulo. Os participantes (N=139) responderam a um questionário semiestruturado. Resultados: para 43 (30,9%) enfermeiros, as prescrições de enfermagem encontram-se, sempre, alinhadas às necessidades cuidativas dos pacientes. As áreas de Cuidado Corporal e Eliminações, Cuidados com Pele e Mucosas e Investigação e Monitoramento foram as mais abordadas. Conclusão: na percepção da maioria dos enfermeiros não há conformidade da prescrição de enfermagem com as necessidades de cuidados dos pacientes. Recomenda-se a implementação de estratégias para aprimorar a qualidade das prescrições, bem como o desenvolvimento de programas de qualificação contínua e a utilização sistemática de instrumentos de avaliação da demanda de atenção do paciente em relação à enfermagem.

Prescribing cascade: A proposed new way to evaluate it

Prescribing cascade is defined as the situation in which a first drug administered to a patient causes adverse event signs and symptoms, that are misinterpreted as a new condition, resulting in a new medication being prescribed. The cascade may have multiple steps and differ in complexity and severity. Despite being well identified, prescribing cascade is an increasingly common problem in medical practice. It constitutes a warning about irrational use of medicines that puts health at risk and increases treatment costs if it is not taken into account. In this article, representative cases taken from Hospital General de Agudos Dr. Cosme Argerich pharmacovigilance database were selected to assess a proper score and an algorithm that define the probable prescribing cascade.

La prescripción en cascada identifica la situación generada tras la administración a un paciente de un medicamento que le provoca un evento adverso, el cual al no ser debidamente reconocido como tal por el profesional desencadena nuevas prescripciones farmacológicas que pueden agravar o generar nuevos eventos adversos. Por ello, de acuerdo a la idiosincrasia de cada paciente, la cascada puede tener múltiples pasos y diferir en complejidad y gravedad. A pesar de estar identificada, la prescripción en cascada es un problema cada vez más común en la práctica médica y una advertencia sobre el uso irracional de los medicamentos que pone en riesgo la salud e incrementa sus costos si no se tiene en cuenta. En este artículo, se seleccionaron casos representativos tomados de la base de datos de farmacovigilancia del Hospital General de Agudos Dr. Cosme Argerich para probar un nuevo score y un algoritmo de decisión, que evalúen la supuesta cascada prescriptiva.

Elaboration and Validation of the Medication Prescription Safety Checklist / Elaboração e validação de Lista de Verificação de Segurança na Prescrição de Medicamentos / Elaboración y validación de Lista de Verificación de Seguridad en la Prescripción de Medicamentos

ABSTRACT Objective: to elaborate and validate a checklist to identify compliance with the recommendations for the structure of medication prescriptions, based on the Protocol of the Ministry of Health and the Brazilian Health Surveillance Agency. Method: methodological research, conducted through the validation and reliability analysis process, using a sample of 27 electronic prescriptions. Results: the analyses confirmed the content validity and reliability of the tool. The content validity, obtained by expert assessment, was considered satisfactory as it covered items that represent the compliance with the recommendations regarding the structure of the medication prescriptions. The reliability, assessed through interrater agreement, was excellent (ICC=1.00) and showed perfect agreement (K=1.00). Conclusion: the Medication Prescription Safety Checklist showed to be a valid and reliable tool for the group studied. We hope that this study can contribute to the prevention of adverse events, as well as to the improvement of care quality and safety in medication use.

RESUMO Objetivo: elaborar e validar um instrumento tipo checklist para identificar a adesão às recomendações na estrutura das prescrições de medicamentos, a partir do Protocolo do Ministério da Saúde e Agência Nacional de Vigilância Sanitária. Método: pesquisa metodológica, conduzida por meio do processo de validade e análise de confiabilidade, com amostra de 27 prescrições eletrônicas. Resultados: análises realizadas confirmaram a validade de conteúdo e a confiabilidade da versão do instrumento. A validade de conteúdo, obtida por meio da avaliação de juízes, foi considerada satisfatória por contemplar itens que representam a adesão às recomendações na estrutura das prescrições de medicamentos. A confiabilidade, avaliada por interobservadores, apresentou-se excelente (ICC=1,00) e de concordância perfeita (K=1,00). Conclusão: o instrumento Lista de Verificação de Segurança na Prescrição de Medicamentos demonstrou-se válido e confiável para o grupo estudado. Espera-se que este estudo possa contribuir para a prevenção de eventos adversos, bem como para a melhoria da qualidade da assistência e segurança no uso de medicamentos.

RESUMEN Objetivo: elaborar y validar un instrumento tipo checklist para identificar la adhesión a las recomendaciones en la estructura de las prescripciones de medicamentos, a partir del Protocolo del Ministerio de la Salud y Agencia Nacional de Vigilancia Sanitaria. Método: investigación metodológica, conducida mediante el proceso de validez y análisis de confiabilidad, con muestra de 27 prescripciones electrónicas. Resultados: los análisis llevados a cabo confirmaron la validez de contenido y la confiabilidad de la versión del instrumento. La validez de contenido, alcanzada mediante la evaluación de jueces, fue considerada satisfactoria por contemplar ítems que representan la adhesión a las recomendaciones en la estructura de las prescripciones de medicamentos. La confiabilidad, evaluada por interobservadores, se reveló excelente (ICC=1,00) y de concordancia perfecta (K=1,00). Conclusión: el instrumento Lista de Verificación de Seguridad en la Prescripción de Medicamentos se mostró válido y confiable para el grupo estudiado. Se espera que este estudio pueda contribuir hacia la prevención de eventos adversos, y también hacia la mejora de la calidad de la atención y seguridad en el uso de medicamentos.

Implementing a clinical pharmacy service in hematology / Implementação de um serviço farmacêutico clínico em hematologia

ABSTRACT Objective: To implement a clinical pharmacy service focused on the comprehensive review of antineoplastic drugs used in therapy of hematological diseases. Methods: An interventional study was conducted in a Brazilian tertiary teaching hospital in two different periods, with and without a clinical pharmacy service, respectively. This service consisted of an antineoplastic prescription validation (analysis of patients' characteristics, laboratory tests, compliance with the therapeutic protocol and with pharmacotechnical parameters). When problems were detected, the pharmacist intervened with the physician or another health professional responsible for the patient. Inpatients and outpatients with hematological diseases were included. Results: We found an increased detection of drug-related problem by 106.5% after implementing the service. Comparing the two periods, an increase in patients' age (26.7 years versus 17.6 years), a predominance of outpatients (54% versus 38%), and an increase in multiple myeloma (13% versus 4%) and non-Hodgkin lymphoma (16% versus 3%) was noted. The most commonly found problems were related to dose (33% versus 25%) and cycle day (14% versus 30%). With regard to clinical impact, the majority had a significant impact (71% versus 58%), and in one patient from the second period could have been fatal. The main pharmaceutical interventions were dose adjustment (35% versus 25%) and drug withdrawal (33% versus 40%). Conclusion: The pharmacy service contributed to increase the detection and resolution of drug-related problems, and it was an effective method to promote the safe and rational use of antineoplastic drugs.

RESUMO Objetivo: Implementar um serviço farmacêutico clínico centrado na revisão completa dos antineoplásicos utilizados no tratamento de doenças hematológicas. Métodos: Estudo intervencional conduzido em um hospital universitário terciário brasileiro em dois períodos distintos, com base na ausência e na presença do serviço farmacêutico clínico, respectivamente. O referido serviço consistiu na validação farmacêutica de prescrição de medicamentos antineoplásicos (análise de características do paciente, exames laboratoriais, conformidade com o protocolo terapêutico e parâmetros farmacotécnicos). Após a detecção dos problemas, o farmacêutico interveio junto ao médico ou outro profissional de saúde responsável pelo paciente. Foram incluídos pacientes internados e ambulatoriais com doenças hematológicas. Resultados: Observou-se um aumento de 106,5% na detecção de problemas relacionados com medicamentos após a implementação do serviço. Comparando-se os dois períodos, verificou-se aumento na idade dos pacientes (26,7 anos versus 17,6 anos), predomínio de pacientes ambulatoriais (54% versus 38%) e aumento de mieloma múltiplo (13% versus 4%) e linfoma não Hodgkin (16% versus 3%). Os problemas mais comumente encontrados foram relacionados à dose (33% versus 25%) e ao dia do ciclo (14% versus 30%). Quanto ao impacto clínico, a maioria apresentou impacto significante (71% versus 58%) e um poderia ter sido fatal no segundo período. As principais intervenções farmacêuticas realizadas foram ajuste de dose (35% versus 25%) e suspensão de medicamento (33% versus 40%). Conclusão: O serviço farmacêutico contribuiu para o aumento da detecção e resolução de problemas relacionados com medicamentos, tratando-se de um método efetivo para promover o uso seguro e racional de medicamentos antineoplásicos.

Legal Aspects of Dental Antibiotic Prescriptions: ADescriptive Study in a Large Brazilian City

Objective:To quantify the antimicrobial drugs most commonly prescribed by dentists since the institution of legal controls in Brazil and to identify the presence of errors in the legal requirements of some of these drugs. Materials and Methods:This is a cross-sectional study of dental antibiotic prescriptions at 69 drug stores in a chain of pharmacies in Belo Horizonte, Brazil. A calculated sample of dental antimicrobial drug prescriptions was selected using simple random sampling from a total of 31,105 prescriptions.The following data were analyzed: the type of antimicrobial drug; the presence of a prescription in accordance with the Common Brazilian Nomenclature (DCB); the name, gender, age and address of the patient; the name, signature, address, telephone number, Regional Dental Council registration number and stamp of the prescriber. After double entry in the Epi-Data program, a descriptive analysis was performed using SPSS version 19.0. Results:A total of 366 dental antimicrobial drug prescriptions were analyzed. The majority of the antimicrobial drugs prescribed were from the penicillin group (71.9%; CI95% 67.0-76.2), 99.7% of which were amoxicillin with or without clavulanic acid. The second most commonly prescribed drugs were the macrolides (16.7%; CI95% 13.2-20.8). The majority (92.8%) had 3 to 5 errors. The most frequent errors were as follows: spelling of the drug name not in accordance with the DCB (72.1%), and the absence of patient information such as age (99.7%), gender (99.8%), and address (87.0%). Conclusion:Antimicrobial drugs of the penicillin and macrolide groups were prescribed most often by dentists, and the majority of those prescriptions had three to five errors, with spelling of the drug name not in accordance with the DCB and missing patient information as the most common errors

Cross-cultural adaptation and content validation of START / Adaptação transcultural e validação de conteúdo do START

CONTEXT AND OBJECTIVE: Non-treatment of diseases or clinical conditions has been considered to constitute omission of care in several countries. The aim of the present study was to develop a transcultural adaptation of the Screening Tool to Alert Doctors to the Right Treatment (START) to Brazilian Portuguese and to validate the tool's content. DESIGN AND SETTING: Cultural adaptation and validation of the START criteria using the Delphi consensus technique. METHOD: START was translated from its original language into Brazilian Portuguese, followed by back-translation and validation by means of the modified Delphi technique. For this, an electronic form was developed and sent to 20 experts, who were asked to use a Likert scale to assess the statements included in START, in relation to their pertinence to Brazilian realities. All of the statements that exhibited mean scores greater than 4.0 were considered to have attained consensus. The experts' identities were kept confidential throughout the validation process. RESULTS: In the first phase of the validation process, 63.6% (14/22) of the statements in START attained consensus. The remaining statements were returned to the experts so that they could have the opportunity to review their comments and statements and to assess them again, based on the Likert scale used earlier. In this phase, 100% of the START instrument attained consensus. CONCLUSION: The content of START was entirely validated for Brazil, with all of the original criteria maintained.

RESUMO CONTEXTO E OBJETIVO: O não tratamento de doenças ou condições clínicas tem sido apontado como omissão no cuidado em diversos países. O objetivo deste estudo foi realizar a adaptação transcultural para o português brasileiro e sua validação de conteúdo do questionário START (Screening Tool to Alert Doctors to the Right Treatment). TIPO DE ESTUDO E LOCAL: Adaptação cultural e validação dos critérios START através da técnica de consenso Delphi. MÉTODO: O START foi submetido à tradução da língua original para o Português (Brasil), tradução reversa e validação de conteúdo por meio da técnica Delphi modificada. Para isso, um formulário eletrônico foi desenvolvido e enviado a 20 especialistas para o julgamento das proposições presentes na ferramenta START conforme sua pertinência para a realidade brasileira, utilizando uma escala de Likert. Foram consideradas consensuais todas as proposições que apresentaram média superior a 4,0. A identificação de cada especialista foi mantida em confidencialidade durante o todo o processo. RESULTADOS: Na primeira fase da validação, foi obtido consenso em 63,6% (14/22) das proposições contidas na ferramenta START. As proposições não consensuais foram reencaminhadas para os especialistas, que tiveram a oportunidade de rever seus comentários e proposições e julgá-las com base na escala de Likert utilizada previamente. Nessa fase, foi obtido consenso em 100% do instrumento START. CONCLUSÃO: O conteúdo do START foi validado para o Brasil na sua totalidade, com todos os critérios originais mantidos.

[Direct-to-consumer advertising for pharmaceuticals in Jordan from a gender perspective]

This study aimed to investigate the extent to which direct-to-consumer advertising [DTCA] for pharmaceuticals is disseminated in Jordan and to identify subsequent gender differences. The study was conducted on two samples: 1] patients [drug consumers] attending Jordan University Hospital, and 2] physicians working at the hospital [prescribers]. A questionnaire was distributed to male and female patients [n=550], and based on its results a second questionnaire was designed and distributed to male and female physicians [n=200]. The response rate was 93% for patients and 72% for physicians. Although the Jordanian Drug and Pharmacy Law prohibits the public promotion of medicines, consumers remain exposed to pharmaceutical advertising. The top ten drug classes advertised directly to consumers in Jordan included prescription-only drugs. Approximately 45% of the two samples agreed that women were more likely to be targeted by DTCA, while only 2% of them believed that men are more likely to be targeted. However, there was no statistically significant gender difference in attitudes towards pharmaceutical DTCA and tools used

Optimización del uso de antibióticos: sugerencias para su implementación / Optimization of antibiotic use: implementation suggestions

Dado el aumento de la resistencia bacteriana y la necesidad de implementar acciones de Control de la Prescripción, este artículo pretende describir experiencias utilizadas en algunos hospitales vinculados a la Universidad de Harvard (Boston, Estados Unidos), con la finalidad de evaluar su utilización en la creación de Programas de Optimización de Uso de Antibióticos en la Red Pública de Salud de Chile y su implementación a través de la Gestión Clínica.

Given the increase in bacterial resistance and the need to implement Prescription Control strategies, this article aims to describe experiences used in a few of the hospitals affilated to Harvard University (Boston, USA), in order to evaluate their use in the creation of Antibiotic Use Optimization Programs for the Chilean Public Health Network, as well their implementation via clinical management.