O Regimento dos preços dos medicamentos... na farmácia brasileira oitocentista / Regulation of drug prices in nineteenth-century Bazilian pharmacy

Resumo Em 5 de novembro de 1808, dom João de Bragança promulgou um alvará sobre o exercício dos boticários e o preço das drogas e ordenou a criação de um regulamento para taxar o custo dos medicamentos comercializados no Brasil. Publicado pela primeira vez em 1809, o Regimento dos preços dos medicamentos... ganhou novas edições nos anos subsequentes e tornou-se um indispensável instrumento de trabalho para os envolvidos com a feitura e o comércio dos remédios. Este texto situa historicamente e destaca esse documento brevemente explorado pelos pesquisadores da história da farmácia brasileira, visto ter sido uma das primeiras iniciativas do governo luso-brasileiro condizentes com a atividade farmacêutica no Brasil no século XIX.

Abstract On November 5th, 1808, D. João de Bragança issued a license about the practice of druggists and the price of drugs and ordered the creation of a regulation to tax the cost of medicines marketed in Brazil. First published on 1809, the Regimento dos preços dos medicamentos... gained new editions in the following years and became an indispensable working tool for those involved in the making and trading of drugs at this time. This paper situates historically and sheds light on a document briefly explored by the researchers of the history of the Brazilian pharmacy, taking into account that it was one of the first initiatives of the Luso-Brazilian government in line with the pharmaceutical activity in Brazil in the nineteenth century.

Direito à saúde, direito à livre concorrência e as limitações territoriais para a instalação de novos estabelecimentos comerciais / Right to health, right to free competition and territorial limitations to establish new shops

O princípio constitucional da livre concorrência, embora não compareça em nosso ordenamento jurídico como valor absoluto, é impassível de restrições irrazoáveis ou desproporcionais pela legislação infraconstitucional. O presente artigo analisa a decisão do Tribunal de Justiça do Estado da Paraíba nos autos da Remessa Oficial n. 017.2011.000010-0/001, que, reafirmando entendimento jurisprudencial já estabelecido,reconheceu a inconstitucionalidade da fixação de distância mínima para instalação de estabelecimentos farmacêuticos, com fundamento no princípio da livre concorrência.

The free competition clause in the 1988 Brazilian Constitution, even though is not an absolute value, does not uphold unreasonable or disproportional restrictions on the competitive environment, even if those restrictions are promoted by a public legislation.This paper analyses the decision from the Paraíba State Court of Justice, in Remessa Oficial n. 017.2011.000010-0/001 that, confirming judicial precedents, declared that the regulation imposing geographic restrictions on entry on the relevant market for pharmacies is unconstitutional, for it is unreasonably anticompetitive.

Riscos do controle e controle dos riscos / Risk of control and control of the risk

A constatação da ilegalidade das restrições geográficas para farmácias oferece oportunidade para se entender melhor a natureza desse estabelecimento comercial, integrado no sistema de saúde. A revisão histórica mostra que os perigos associados ao preparo e a disponibilização de medicamentos passaram a ser controlados por regulamentação do Estado a partir do século XIII na Europa. No sistema de guilda, restrições foram impostas, não só para o exercício profissional, mas também para preços e localização geográfica. Seu propósito foi excluir incertezas na saúde pública através da garantia da qualidade e da possibilidade de acesso ao medicamento. Todavia, essas condições mudaram ao longo do século XX, com a prevalência de medicamentos industrializados à disposição via economia de mercado. Nesta, os melhores termos de troca se dão preferencialmente sob aglomeração geográfica, que reduz as expectativas de risco dos envolvidos, baixando os preços. De maneira geral, não há consenso internacional em se continuar mantendo ou não as restrições geográficas. Mas o custo crescente da universalização do acesso à saúde vem tornando necessária a revisão da segurança proporcionada pelas restrições profissionais em prol de uma lógica de incerteza configurada em risco.

The decision of the Paraíba State’s Court to not obstruct the geographical concentration of pharmacies offers opportunity to better understand the nature of this commercial establishment, integrated to the health system. The historical review shows that the hazards associated with the preparation and availability of drugs began to be controlled by state regulations in the 13th century in Europe. In the guild system, restrictions were imposed, not only for practice, but also for pricing and geographic location. Its purpose was to exclude uncertainties in public health by ensuring the quality and the possibility of access to medicines. However, these conditions have changed through the 20th century, with the prevalence of manufactured drugs available via market economy. In it, the best terms of trade are given preferably within cluster, which reduces the risk expectations of those involved, lowering prices. In general, there is no international consensus on whether or not to maintain geographical restrictions. Nevertheless, the rising cost of universal access to health care makes it necessary to review the security provided by professional restrictions on behalf of a logic of uncertainty configured at risk.

Restricción de la venta de antibióticos en farmacias de Bogotá, Colombia: estudio descriptivo / Restriction of antibiotic sales in pharmacies in Bogotá, Colombia: a descriptive study

Objetivo. Describir el estado de la aplicación de la norma relacionada con la prohibición dela venta de antibióticos sin prescripción médica en farmacias de Bogotá, Colombia. Métodos. Estudio descriptivo transversal, en el cual se utilizó la técnica de simulación de compra en farmacias (droguerías) de Bogotá. La muestra de 263 farmacias se calculó con una precisión de 5% y un factor de corrección de 2% mediante estratificación (farmacias de cadenae independientes) y asignación aleatoria simple en cada estrato. Resultados. Del total de farmacias estudiadas, 80,3% no cumplen la norma que establecela venta de antibióticos con receta. En 20,1% de los casos, el expendedor indagó la edad del paciente o sus síntomas o ambos, con el fin de ofrecer otros medicamentos o para cambiar elantibiótico. En ninguna oportunidad se preguntó por antecedentes personales de alergia a los antibióticos. En los casos en los cuales hubo intención de venta del antibiótico, la presentación genérica fue la más comúnmente ofrecida (81,2%). Algunos expendedores de medicamentos hicieronrecomendaciones inapropiadas. Las localidades con mayor incumplimiento de la norma coinciden con aquellas que tienen altas tasas de necesidades básicas insatisfechas. Conclusiones. A cinco años de adopción de la norma orientada a contrarrestar la ventalibre de antibióticos, su cumplimiento es mínimo y la entrega no se realiza de acuerdo a los parámetros establecidos. El personal de farmacia no suministra la información requerida de acuerdo con sus competencias.

Objective. Describe the implementation status of a regulation prohibiting antibiotic sales without a medical prescription in pharmacies of Bogotá, Colombia. Methods. A cross-sectional descriptive study was conducted using the simulated purchase technique in Bogotá pharmacies (drugstores). The sample of 263 pharmacies was calculated by stratification (chain pharmacies and independent pharmacies) with 5% accuracy and a 2% correction factor. Simple randomization was assigned in eachstratum. Results. Out of the total pharmacies studied, 80.3% did not comply with the regulation established for prescription sales of antibiotics. In 20.1% of the cases, the dispenser asked about the patient’s age, symptoms, or both age and symptoms in order to offer other drugs or change the antibiotic. There were no inquiries about amedical history of allergy to antibiotics. In cases in which there was the intention to sell antibiotics, the generic format was most commonly offered (81.2%). Some drug dispensers made inappropriate recommendations. The locations with the highest levels of noncompliance with the regulation were also those with high rates of unmetbasic needs. Conclusions. Five years after passage of a regulation to halt the unrestricted sales of antibiotics, there is minimal compliance, and dispensing does not conform to the established parameters. Pharmacy personnel do not provide the required information according to their responsibilities.

Consumo comunitario de antimicrobianos en Chile, 2000-2008 / Community antibiotic consumption in Chile, 2000-2008

Background: The Chilean Ministry of Health has implemented regulatory rules for the consumption of anti-biotics since September 1999, with sales restriction limited only with medical prescription. Aim: To analyze the impact of established regulatory measures from 2000 to 2008. Material and Methods: A retrospective analysis of antibiotics sales in pharmacies from 2000 to 2008 was performed. The information was obtained from the International Marketing System (IMS Health), an auditing system of pharmacy sales. The consumption unit used was the Defined Daily Dose per 1000 inhabitants/day (DDD). Results: From 2000 to 2002 the regulatory rules had a great impact, but since 2002 the antibiotic consumption increased, especially amoxicillin, returning to similar levéis observed in 1998. Conclusions: The regulatory measures had an initial impact, but there was not reinforcement in the time and there was no further control. It is necessary to assume a permanent task and support of the authorities of health to edúcate the population about the implications of the inadequate use of antimicrobials and his effect on the microbial ecology.

Introducción: El Ministerio de Salud de Chile reguló el consumo de antimicrobianos en el mes de septiembre de 1999, mediante restricción de venta limitada sólo a venta con receta médica. El objetivo de este estudio es conocer el impacto de las medidas regulatorias entre los años 2000 y 2008. Metodología: Se realizó un análisis retrospectivo de las ventas en farmacias privadas desde el año 2000 al 2008. La información se obtuvo del International Marketing System Health (IMS Health), una empresa internacional encargada de auditar las ventas de farmacias. La unidad de consumo usada fue la DDD/1.000 habitantes-día. Resultados: A partir del año 2000 al 2002, las medidas regulatorias tuvieron un gran impacto; sin embargo, desde el año 2002 el consumo de antimicrobianos aumentó, especialmente amoxicilina, obteniéndose valores similares a los existentes en 1998. Conclusiones: Las medidas regulatorias tuvieron un impacto inicial; sin embargo, no fueron reforzadas ni controladas en el tiempo. Es necesario que las autoridades de salud del país asuman la tarea pennanente de educar a la comunidad acerca del uso inadecuado de antimicrobianos y su efecto sobre la ecología bacteriana.

Dispensação farmacêutica: uma análise dos conceitos legais em relação à prática profissional / Pharmaceutical dispensing: an analysis of legal concepts in relation to professional practice

O âmbito profissional do farmacêutico sofreu mudanças ao longo dos anos, provocando a descaracterização das farmácias comunitárias em virtude da acentuada concepção mercantil que vem apresentando e do distanciamento do farmacêutico na relação direta com a comunidade. Dessa forma, a dispensação de medicamentos se tornou um ato mecânico, desprovido dos cuidados necessários para a assistência à saúde, havendo, contudo, uma tendência de incorporação de novas práticas. Nesse sentido, ao estudar os conceitos de dispensação explicitados nas legislações sanitárias e profissionais brasileiras, esse artigo tem como objetivo analisá-los em relação ao contexto atual. Trata-se de um estudo teórico, realizado com a técnica da análise de conteúdo. Os resultados mostram que apesar das necessidades e novas demandas apontadas no cenário farmacêutico, ocorreram poucas mudanças nos conceitos de dispensação nas legislações estudadas, apontando a necessidade de se reafirmar a dispensação como atividade inserida no contexto da assistência à saúde.

The pharmacist?s professional scope of practice has changed over the years, causing a loss of the special role of community pharmacies, due to the strongly market-oriented conception that is emerging and the distancing of the pharmacist from a direct relationship with the community. Thus, the dispensing of drugs has become a mechanical act, devoid of the care necessary for health provision, there being, however, a tendency to incorporate new practices. Therefore, by studying the concepts of dispensing spelled out in the health laws and by health professionals in Brazil, the aim of this article is to analyze them in relation to the current context. This is a theoretical study, carried out by the technique of content analysis. The results show that despite the new demands and requirements noted in the pharmaceutical scenario, there have been few changes in the concepts of dispensing in the laws examined, indicating a need to reaffirm dispensing as an activity that has a place within the context of health care.

Essai de mise au point d'un code de la pharmacie au Mali : partie legislative

Du fait de la colonisation (1895-1960) le Mali a ete soumis au plan legislatif et reglementaire a un corpus de textes nombreux et epars se rapportant au secteur de la pharmacie. Il s'agit entre autre de la Loi An XI du 21 Germinal ou Loi du 11 avril 1803; du contenu du livre V du Code de la Sante Publique relatif a l'exercice de la pharmacie; dont certaines dispositions ont ete etendues aux territoires d'Outre-Mer; au Togo et au Cameroun en 1953 ; de l'Arrete de 1955 sur la repartition des officines en AOF ; de la Loi de 1960 portant creation de l'Ordre des pharmaciens dans la federation du Mali etc.. Apres l'accession a la souverainete internationale; le nouvel Etat Malien tout en reconduisant la legislation pharmaceutique issue de l'Etat anciennement tuteur qui n'etait pas contraire a la nouvelle loi fondamentale; a egalement mis en place; conformement aux orientations politiques de l'heure; de nouveaux textes. Dans le cadre de ce travail; nous avons recense l'ensemble des textes legislatifs et reglementaires qui ont ete pris au Mali dans le secteur pharmaceutique et celui des etudes en pharmacie. Nous avons fait l'examen critique de ces textes et procede a la codification de la partie legislative. Le present code est presente en 189 articles repartis en 5 titres disposes en chapitres et en sections

Quality of pharmaceutical items available from drugstores in Phnom Penh, Cambodia.

Drugstores and drug outlets are the main sources of care for the majority of Cambodian citizens because of the availability of drugs, short waiting time, and ability to control the cost of treatment. Unfortunately, no enforcement of pharmacy regulations and little consumer and drugstore personnel education contribute to a potential harmful unregulated drug market resulting in high costs and prolonged illness. No study has looked at the quality of over-the-counter drugs, which would have the highest impact on the people. In this study, we were interested in exploring the quality of commonly used pharmaceutical items available from drugstores in Phnom Penh, Cambodia, using uncoated aspirin tablets as a case study. Factors relating to quality of the drug were also examined. This study was conducted by means of drug fishing method to obtain uncoated aspirin tablet samples from 96 drugstores in Phnom Penh. The quality of the samples was examined in six aspects: percent label amount, weight variation, hardness, percent friability, disintegration time, and dissolution rate. We found that only seven (7.3%) of the total 96 samples passed all six quality criteria. Dissolution test appeared to be the most critical step in determining aspirin quality. Factors that were statistically related to the quality of the sample were type of packaging. All the drugs that passed the six criteria were in bottles. Source of the medications was also significantly related to their quality. Among seven samples that passed the test, six were from Vietnam. Our study revealed that the quality of uncoated aspirin tablets was a serious problem. The vast majority of the samples did not meet the standard requirements. Type of packaging and source of medications were related to the quality of samples. This study has important implications for the Cambodian government regarding the control of the quality of pharmaceutical items available in drugstores.

La edad del paciente: factor determinante para la prescripción de medicamentos en las farmacias de Santiago / The patient age: decisive factor for drug prescriptions in pharmacies of Santiago

Para averiguar si la edad de los niños influye en la prescripción de medicamentos por parte de las farmacias, se encuestaron los dependientes de 67 de estos establecimientos en distintas comunas de Santiago, Chile, mediante una consulta simulada sobre una enfermedad respiratoria en un niño de edad escolar y un lactante. Las respuestas se registraron en formularios tipo, con el nivel socioeconómico (NSE) asignado a la comuna del establecimiento, pertenencia a cadenas farmacéuticas, sexo y profesión del encuestado. la evaluación estadística de resultados dicotómicos incluyó prueba de Fisher-Irwing. No se derivó a médico 77,6 por ciento (104/134) de las consultas, formulándose diagnósticos en todos estos casos (104/104), los que siempre originaron prescripción de medicamentos, frecuentemente antibióticos 50 por ciento (67/134), dilatándose la consulta médica en 55,2 por ciento (74/134) de los casos, lo que fue más acentuado si el dependiente era varón y la farmacia estaba en un barrio de NSE medio-bajo. El lactante fue más frecuentemente derivado a médico (58 por ciento vs 3 por ciento, p=1,85ù10-8), prescribiéndosele menos veces antibióticos (96 por ciento vs 42 por ciento, p=7,7 x 10-9), independientemente de todas las demás variables investigadas. La edad menor de un año constituye un factor limitante a la prescripción directa de medicamentos en las farmacias encuestadas

La receta retenida: un problema médico-legal / The prescription retention: a medical-legal problem

Se investigó el conocimiento que poseen los médicos y químico-farmacéutico (QF) del uso de la receta retenida (RR) y la legalidad vigente, que regula el expendio de fármacos controlados. Se realizó un estudio descriptivo, prospectivo, que consistió en una prueba de simulación, en farmacias del área oriente de Santiago y se encuestó a QF y médicos durante el mes de diciembre de l990. Del estudio se concluye que en más de un tercio de las farmcias l RR no es recibida por el QF como establece la ley. Sólo se rechazaron un l5.6 por ciento de las recetas incompletas presentadas. Un 78.3 por ciento de los QF desconocen la mayoria de los requisitos legales que debe cumplir la RR la RR no cumple el objetivo para el cual se creó: evitar la venta indiscriminada de ciertos medicamentos y la farmacodependencia