Pharmaceutical evaluation of compounded furosemide capsules and excipient performance

Abstract Compounding pharmacies play an important role not only in compounding personalized formulations, but also preparing drugs at the same concentration and dosage as those from commercial manufacturers. The excipients used in compounding are generally standardized for many drugs, however they do not consider the intrinsic properties, such as the poor water solubility, of each substance. The excipient performance of commercially available compounded furosemide capsules in 7 compounding pharmacies from Manaus was evaluated and compared them to the performance of the reference medicinal product (Lasix® tablets) and 2 batches of capsules made in-house (T2 and T4) with a standardized excipient. All batches were subjected to tests for weight variation, assay, uniformity of dosage units, disintegration and dissolution profile. Of the 7 different compound formulas acquired in the compounding pharmacies, only 2 passed all tests. Most formulas passed the tests for weight determination, disintegration time and assay, however batches from 2 establishments failed in regards to the uniformity of the content and 5 batches failed the dissolution test. The reference medicinal product was approved in all tests, as were the T2 capsules made in-house with drug-excipient ratio 1:2. These results confirm the importance of the excipient composition, especially for poorly soluble drugs.

Cumplimiento de la normatividad en droguerías con servicio de glucometría en cuatro ciudades de Santander, Colombia / Regulation Compliance in drugstores with glucometry service in four cities of Santander-Colombia

RESUMEN Objetivo Evaluar el cumplimiento normativo del servicio de glucometría en droguerías del departamento de Santander-Colombia. Métodos Estudio observacional descriptivo de corte transversal. Se usó un instrumento de evaluación basado en la norma y validado por expertos. Resultados Se aplicó una encuesta a 68 droguerías. Los resultados fueron categorizados así: recursos humanos, dotación, infraestructura, documentación-registro y procesos de vigilancia y control. En la primera categoría se identificaron falencias relacionadas con la formación académica del personal a cargo de la droguería, con un porcentaje de cumplimiento del 66,2% y en la capacitación del personal en el manejo del equipo de glucometría 35,3%. En general el conocimiento de la normatividad por parte del personal fue de 36,8%. En las categorías de dotación e infraestructura se evidencia un nivel de cumplimiento superior al 50% para todos los ítems, excepto el relacionado con la calibración del equipo. En la cuarta categoría, específicamente en documentación y registro, los niveles de cumplimiento normativo son inferiores al 50% en todos los ítems, excepto el de información, que se le ofrece al paciente durante el procedimiento. Los resultados evidencian una falla en los procesos de vigilancia y control, dado que solo el 57,4% de los establecimientos confirman visitas de inspección. Conclusiones Los resultados de este estudio revelan un desconocimiento generalizado de la normatividad en droguerías que prestan el servicio de glucometría; consecuentemente, no se cumplen todas las exigencias regulatorias. Fomentar programas de capacitación y fortalecer la cultura de la autoevaluación garantiza procesos seguros para el paciente.(AU)

ABSTRACT Objective To evaluate the compliance of the service of glucometry in drugstores in the department of Santander - Colombia. Methods Cross-sectional observational study. An assessment instrument based on the normativity and validated by experts was used. Results The poll was applied to 68 drugstores. The results were categorized as follows: human resources, equipment, infrastructure, documentation - registration, and surveillance and control processes. In the first category, shortcomings related to the academic training of the staff in charge of the drugstore were identified, with a compliance percentage of 66,2% and in the training of personnel in the management of the glucometry equipment, 35,3%. In general, the knowledge of the regulations by the staff was 36,8%. In the equipment and infrastructure categories, a level of compliance of more than 50% is evident for all items, xcept in those related to calibration equipment. In the fourth category, specifically in documentation and registration, the levels of regulatory compliance are less than 50% in all items, except in the one related with the information that is offered to the patient during the procedure. The results show a failure in the surveillance and control processes, where only 57,4% of the establishments confirm inspection visits. Conclusions The results of this study reveal widespread ignorance of the regulations in drugstores that provide the glucometry service; consequently, not all regulatory requirements are met. Promoting training programs and strengthening the culture of self-evaluation guarantees safe processes for the patient.(AU)

Reasons why insured consumers co-pay for medicines at retail pharmacies in Pretoria, South Africa

Background: Costly prescription medicines with existing cheaper alternatives tend to be purchased by medically insured consumers of healthcare. In South Africa medical scheme members pay higher out-of-pocket payments for medicines than those without insurance.Aim: This study explored reasons for co-payments among insured Pretoria medical scheme members purchasing prescription medicines at private retail pharmacies, despite being insured and protected against such payments. Setting: The study took place in retail pharmacies in Pretoria, Gauteng Province, South Africa.Methods: An exploratory qualitative study was performed. Semi-structured interviews were conducted among purposefully sampled medical scheme members (12) and nine key informants (six pharmacists and three regulators ­ one for the pharmaceutical industry, one for medical schemes and one for pharmacists). Three pharmacies (two corporate and one independent) each were identified from high and low socio-economic areas. Scheme members were interviewed immediately after having made a co-payment (eight) or no co-payment (four) from the selected pharmacies. Interviews were recorded, coded and organised into themes.Results: Co-payments were deemed confusing, unpredictable and inconsistent between and within pharmacies. Members blamed schemes for causing co-payments. Six sampled pharmacies rarely stocked the lowest-priced medicines; instead, they dispensed medicines from manufacturers with whom they had a relationship. Corporate pharmacies were favoured compared to independents and brand loyalty superseded cost considerations. Medical scheme members did not understand how medical schemes' function.Conclusion: Unavailability of lowest-priced medicines at pharmacies contributes to co-payments. Consumer education about generics and expedited implementation of National Health Insurance could significantly reduce co-payments

Infrastructure of pharmacies of the primary health care in the Brazilian Unified Health System: Analysis of PNAUM - Services data / Infraestrutura das farmácias da atenção básica no Sistema Único de Saúde: Análise dos dados da PNAUM-Serviços

ABSTRACT OBJECTIVE To characterize the infrastructure of the primary health care pharmacies of the Brazilian Unified Health System, aiming at humanizing the offered services. METHODS This is a cross-sectional study, of quantitative approach, from data obtained in the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços, 2015 (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines - Services, 2015). Information on 1,175 pharmacies/dispensing units were gathered from direct observation and assessment of dispensing units installations conducted by trained researchers who used a standardized form. The analyzed variables refer to the physical structure of pharmacies or medicine dispensing units of the health units under research. RESULTS The pharmacy area was greater than 14 m2 in 40.3% of the sampled units, highlighting those from Midwest (56.9%) and Southeast (56.2%) regions and those of Northeast, with only 23.3%. About 80.2% units had waiting rooms with chairs for patients, 31.8% of them had dispensing areas inferior to 5m2, while in 46.2% these areas were superior to 10m2. Bars were found in service counters in 23.8% of health units, thus separating the patient from the professional; 44.1% had internet access. In most units, the area of medicine storage had no refrigerator or freezer for their exclusive storage and 13.7% had a specific room for pharmaceutical consultation. CONCLUSION Aiming at achieving care humanization and improving working conditions for professionals, the structuring of the environment of pharmacy services is necessary. This would contribute to the better qualification of pharmacy services, comprising more than medicine delivery. Data on the Northeast region indicated less favorable conditions to the development of adequate dispensing services. Based on the panorama pointed out, we suggest the expansion of stimulus concerning the physical structure of pharmaceutical services, considering regional specificities.

RESUMO OBJETIVO Caracterizar a infraestrutura das farmácias da atenção básica do Sistema Único de Saúde, visando condição para a humanização dos serviços ofertados. METODOS Trata-se de estudo transversal, de abordagem quantitativa, a partir de dados obtidos da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços, 2015. As informações de 1.175 farmácias/unidades de dispensação foram oriundas de observação direta e mensuração das instalações das unidades de dispensação realizadas por pesquisadores treinados e uso de formulário padronizado. As variáveis analisadas referem-se à estrutura física das farmácias ou unidades de dispensação de medicamentos das unidades de saúde amostradas. RESULTADOS A área da farmácia foi superior a 14 m2 em 40,3% das unidades pesquisadas, com destaque para as regiões Centro-Oeste (56,9%) e Sudeste (56,2%) e Nordeste com apenas 26,3%. A sala de espera possuía cadeiras para os usuários (80,2%), em 31,8% a área de dispensação era inferior à 5m2 e em 46,2% foi superior a 10m2. Foram encontradas grades no guichê de atendimento, separando o atendente do usuário em 23,8% das unidades; havia acesso à internet em 44,1%. Na maioria das unidades, a área destinada ao armazenamento de medicamentos não possuía refrigerador ou geladeira para o seu armazenamento exclusivo e 13,7% apresentavam área para consulta farmacêutica. CONCLUSÕES É necessária a estruturação da ambiência dos serviços de farmácia visando a humanização do atendimento e a melhoria das condições de trabalho aos profissionais. Isso propicia melhor qualificação do serviço de farmácia para além da entrega do medicamento. Os dados apresentados pela região Nordeste indicam condições menos favoráveis ao desenvolvimento de serviços de dispensação adequados. Com base no panorama apontado, sugere-se a ampliação dos incentivos para a estruturação física dos serviços farmacêuticos, levando em consideração as especificidades regionais.

Propuesta de indicadores de resultados y de recursos para farmacias comunitarias cubanas / Proposal of result indicators and of resource indicators for Cuban community drugstores

Introducción: los farmacéuticos cubanos están convocados por los principales dirigentes del país a utilizar con eficiencia los recursos existentes. Para cumplimentar lo anterior, y con el objetivo de implementar futuros estudios de eficiencia en las farmacias comunitarias, es imprescindible determinar los parámetros que pueden ser utilizados como indicadores de recursos y de resultados. Objetivos: identificar indicadores de resultados y de recursos para las farmacias comunitarias. Métodos: se desarrolló una investigación observacional. Se realizó una revisión bibliográfica y documental y la consulta a expertos. Se definieron como variables a Indicadores de resultados: aquellos que reflejen la consecución tangible del objeto social de la institución e Indicadores de recursos: conjunto de recursos materiales, humanos y financieros que se consume en el logro de un resultado específico. Resultados: la propuesta de indicadores de resultados para las farmacias comunitarias es la siguiente: satisfacción de la población, ventas, supervisiones satisfactorias, faltantes o sobrantes, abastecimiento de medicamentos, abastecimiento de medicamentos naturales, abastecimiento de medicamentos químico dispensariales. La propuesta de indicadores de recursos para las farmacias comunitarias resultó en: salario mensual devengado, costo de adquisición de mercancías, otros gastos. Conclusiones: se identificaron indicadores de resultados y de recursos para las farmacias comunitarias sustentados en la información disponible y ajustada a las características propias de estas unidades en el contexto sanitario cubano(AU)

Introduction: the Cuban pharmacists are called upon by the main leaders of the country to efficiently use the existing resources. For attaining the above-mentioned and for implementing future efficiency studies in the community drugstores, it is indispensable to determine the parameters that may be used as result and resource indicators. Objectives: to identify the result and the resource indicators for the community drugstores. Methods: observational research, literature and documentary review and expert consultation. Result indicators were defined as those reflecting the tangible attainment of the social object of the institution and resource indicators were a set of material, human and financial resources that are consumed in fulfilling a specific result. Results: the proposal of result indicators for the community drugstores is the following: population's satisfaction, sales, right supervisions, shortages and surpluses, drug provision, natural drug supply,and supply of chemical drugs. The proposal of resource indicators for the community drugstores were monthly salary paid, cost of product purchase and other costs. Conclusions: several result and resource indicators were determined for the community drugstores based on available information, according to the characteristics inherent to these units in the Cuban health care setting(AU)

Fatores facilitadores e dificuldades no exercício da vigilância sanitária de farmácias em Salvador-Bahia / Facilitating factors and difficulties in the the implementation of sanitary surveillance of drugstores in Salvador, state of Bahia, Brazil

A farmácia é o estabelecimento de saúde onde são dispensados medicamentos, razão que a justifica como objeto de intervenção da vigilância sanitária. Esta utiliza variadas tecnologias para seu controle de risco. Neste estudo utilizou-se referencial da teoria do processo de trabalho em saúde com o objetivo de descrever e analisar facilidades e dificuldades encontradas no exercício da vigilância sanitária de farmácias em Salvador. Adotou-se a estratégia metodológica de estudo de caso, com categorias analíticas facilidades e dificuldades inerentes aos técnicos, farmácia, serviço de vigilância sanitária e ao meio social. Dados foram coletados por meio das técnicas de observação direta e entrevistas semiestruturadas. As falas foram tratadas por meio da análise de conteúdo. O corpus foi processado e categorizado utilizando-se o software QSR N VIVO. Depreende-se que a natureza das facilidades e dificuldades encontradas na realização das atividades de vigilância sanitária de farmácias indicam a necessidade de mudanças emergenciais no âmbito dos serviços e na cultura sanitária do país. Também aponta para a possibilidade de oferta de um serviço de qualidade na proteção da saúde, num cenário favorável ao desenvolvimento da vigilância sanitária como processo de descentralização destas ações.

Drugstores are the health establishments where medications are dispensed, which is why sanitary surveillance is justified as a means of intervention. The health department uses various technologies to control risk in drugstores. In this study we used the theory of the process of work in health as a benchmark in order to describe and analyze the strengths and difficulties encountered in sanitary surveillance in drugstores in Salvador. Case study methodological strategy was adopted, the analytical categories being facilitating factors and difficulties inherent to technicians, drugstore, sanitary surveillance service and the social environment. Data were collected through direct observation techniques and semi-structured interviews, and the findings were assessed using content analysis. The body of information was processed and categorized using QSR N VIVO software. It was revealed that the nature of the facilitating factors and difficulties found in surveillance activities of drugstores indicate the need for urgent change within the scope of services and the sanitary culture in the country. It also stresses the possibilities of offering a quality service for the protection of health, in a setting conducive to the development of sanitary surveillance and the process of decentralization of these actions.

Trabalho em saúde: vigilância sanitária de farmácias no município de Salvador (Bahia, Brasil) / Work in health: sanitary surveillance of drugstores in Salvador (state of Bahia, Brazil)

A farmácia é um estabelecimento de interesse da saúde onde são dispensados medicamentos, tecnologia terapêutica mais utilizada na prática médica. Este trabalho objetiva descrever e analisar a vigilância sanitária de farmácias. A partir da teoria do processo de trabalho em saúde, realizou-se um estudo sobre a vigilância sanitária em farmácias de Salvador (Bahia, Brasil), segundo as categorias analíticas agentes e atividades. Os dados foram coletados por meio da observação, análise documental e entrevistas. No processamento, utilizou-se o software QSR N Vivo. Verificou-se multiprofissionalidade no quadro técnico, profissionais com pouco tempo de serviço em vigilância sanitária de farmácias e insuficiente capacitação técnica para o exercício das atividades. Foram observadas deficiências de ordem gerencial no serviço, que ainda não incorporou práticas de planejamento e avaliação. As atividades estão direcionadas à concessão da licença sanitária, priorizando-se o atendimento à demanda espontânea, configurando um modelo tecnológico de intervenção baseado na inspeção sanitária. Revelou-se a necessidade de modernização do serviço e utilização de tecnologias diversificadas para propiciar o controle do risco, dado que a evolução tecnológica oferece medicamentos cada vez mais potentes, porém com maior grau de risco.

A drugstore is an establishment of interest in health, from which medication is dispensed, namely the therapeutic technology most broadly used in the practice of medicine. The scope of this study is to describe and analyze the sanitary surveillance of drugstores. Based on the theory of working processes in healthcare, a case study was conducted on the sanitary surveillance of drugstores in Salvador (Bahia, Brazil), examining 2 analytical categories: agents and activities. Data were collected through observation, analysis of documents and interviews, and QSR N Vivo software was used for data processing. Personnel of the surveillance service were found to have varied professional and educational backgrounds, with limited experience in the sanitary surveillance of drugstores, and insufficient technical training for the performance of the tasks assigned. Deficiencies of a managerial nature were detected in the service. Its operation is primarily focused on granting drugstore licenses, prioritizing attendance to spontaneous demand, thereby configuring a technological model of intervention based on sanitary inspection. The findings revealed a need for updating the service and the adoption of technologies to enhance control of risk, given that technological evolution provides drugs that are increasingly more potent, with a concomitant rise in levels risk.

Prescrição, dispensação e regulação do consumo de psicotrópicos anorexígenos em Belo Horizonte, Minas Gerais, Brasil / Prescription, dispensing, and regulation of psychoactive anorexigenic drugs in Belo Horizonte, Minas Gerais, Brazil

Estudo retrospectivo, realizado na cidade de Belo Horizonte, Minas Gerais, Brasil, para avaliar indicadores de dispensação e consumo de substâncias anorexígenas. Ocorreu em duas etapas: na primeira, foram analisadas 2.906 das 168.237 notificações de receitas aviadas por estabelecimentos farmacêuticos da cidade, em 2003. Observou-se uma baixa qualidade nas notificações. O consumo projetado foi de 19,75 DDD/mil habitantes/dia. A substância mais consumida foi o fenproporex (59,8 por cento). Uma farmácia foi responsável por 39,8 por cento das dispensações. Na segunda etapa, foram analisados 14.554 registros do livro de receituário geral da farmácia que mais dispensou tais produtos, no período de abril a agosto de 2005. Os anorexígenos responderam por 9,2 por cento das manipulações e 91,8 por cento deles foram prescritos para uso concomitante com outra substância: 43 por cento com clordiazepóxido, 50,6 por cento com fluoxetina, 7,5 por cento com outro anorexígeno e 28,2 por cento com bromazepam. Os resultados observados sugerem um uso indiscriminado e irracional de anorexígenos neste município, sendo fundamental aprimorar a regulação do mercado de produtos manipulados. Para tanto, é necessário uma melhor compreensão do papel da farmácia nessa regulação e o papel dos prescritores no uso racional dessas substâncias.

This retrospective study in Belo Horizonte, Minas Gerais, Brazil, aimed to provide indicators on the sale and consumption of anorexigenic substances. During the first stage, 2,906 of 168,237 prescriptions received by pharmacies in 2003 were analyzed, showing low quality of prescriptions. Projected consumption in defined daily doses was 19.75 DDD/1,000 inhabitants/day in 2003. Fenproporex (59.8 percent) was the most widely consumed drug. One pharmacy was responsible for 39.8 percent of the pharmaceutical sales. During the second stage, 14,554 sales records from this "blockbuster" pharmacy were analyzed, from April to August 2005; 9.2 percent of sales were for anorexigenic products, 91.8 percent of which prescribed in association with another substance. The data suggest irrational use of anorexigenic drugs by these consumers and highlight the need for proper regulation of these products. It is important to understand both the role of pharmacies in this regulation and that of physicians in the rational use of these substances.

Prescriçäo imprópria de antibióticos para tratamento de rinossinusite por farmácias de Caxias do Sul / Uncorrectly indications the antibiotics of treatment of sinusitis in Caxias do Sul

Sinusite é uma doença frequentemente diagnosticada na prática médica, e seu tratamento é realizado através de antibióticos. O excesso de diagnóstico e da antibioticoterapia sem indicaçäo ou sem critérios têm contribuído para o aumento da resistência bacteriana. Com o objetivo de verificar a indicaçäo imprópria de drogas nas "consultas farmacêuticas", realizaram-se visitas a 45 farmácias de Caxias do Sul, queixando-se de sintomas de sinusite aguda. Das farmácias consultadas, somente 17,8 por cento sugeriram consulta com um especialista, exclusivamente, enquanto que 44,4 por cento delas indicaram o uso de antibióticos e 37,8 por cento indicaram antiinflamatórios, descongestionantes tópicos e sistêmicos e consulta médica caso näo fosse obtida melhora. Os autores revisaram aspectos no tratamento e complicaçöes das sinusites, a fim de comparar a medicaçäo prescrita com a preconizada na literatura. Salientam também aspectos da resistência bacteriana, resultantes do uso indiscriminado de antibióticos nessas patologias.

Pharmacy distribution of advice, symptomatic treatment and antimicrobial drugs to patients with cough

It i an accepted fact that, in many countries, pharmacies are the predominat source of medical advice over-the-counter drugs, and supplies of "prescription-only" drugs for sale without a prescription. To assess the activities conducted by pharmacists or pharmacy counter assistants in response to a common health problem, a cross-sectional study was done at 114 pharmacies in Porto Alegre, Brazil. A fictitious case-history of cough was used by trained personnel entering the pharmacy and the subsequent activities by the pharmacist or pharmacy counter assistant were analyzed. Some kind of medication was provided in 101 (88.5 percent)of the pharmacies. Pharmacists gave medication in 80 percent of pharmacies, and pharmacy assistants in 95.5 percent (p<0.03). The class of medication most frequently dispensed was the expectorants (97 times, 92.4 percent), however, systemic antibiotics were provided in 11 pharmacies (10.5 percent). Of note, the pharmacists provided antibiotics more frequently than did pharmacy assistants (p=0.016). We conclude that pharmacy advice and symptomatic medical care (expectorants) are very common and that pharmacy assistants are more likely than pharmacists to provide medication. Of concern, when pharmacists were the drug dispensers of antibiotics which should be provided by prescription only, drugs were provided without proper diagnosis, and often incorrect dosages. This reflects a pontentially dangerous practice in need of careful evaluation, education and supervision.

Situación del servicio de turno de farmacias y boticas / Situation of pharmacies and apothecaries service

El presente trabajo pretende llevar a cabo el dignóstico del servicio de turno que se realiza en farmacias y boticas a nivel de Lima Metropolitana, y que representan más del 50 por ciento de farmacias y boticas de las existentes en nuestro país. Se presentará una revisión histórica de este servicio enfocándose cómo, cuándo y porqué se organiza este tipo de servicio en nuestra comunidad, iniciando en la segunda mitad del siglo pasado; y de cómo ha ido evolucionando hasta nuestros días. En un segundo momento se analizará en forma comparativa los diferentes reglamentos que se han venido estableciendo a través de los años, hasta arribar en un análisis profundo al actual reglamento y al anteproyecto existente, donde se enfatizará la revisión de las normas legales que rigen su ejecución. Finalmente se presentará el análisis actual de la situación del servicio de turno precisándose puntos como: el uso del servicio de turno por la población, la seguridad en la prestación del servicio, grupos de medicamentos requeridos, así como otros aspectos muy importantes.