Socioeconomic Determinants of Antibiotic Consumption in the State of São Paulo, Brazil: The Effect of Restricting Over-The-Counter Sales.

BACKGROUND: Improper antibiotic use is one of the main drivers of bacterial resistance to antibiotics, increasing infectious diseases morbidity and mortality and raising costs of healthcare. The level of antibiotic consumption has been shown to vary according to socioeconomic determinants (SED) such as income and access to education. In many Latin American countries, antibiotics could be easily purchased without a medical prescription in private pharmacies before enforcement of restrictions on over-the-counter (OTC) sales in recent years. Brazil issued a law abolishing OTC sales in October 2010. This study seeks to find SED of antibiotic consumption in the Brazilian state of São Paulo (SSP) and to estimate the impact of the 2010 law. METHODS: Data on all oral antibiotic sales having occurred in the private sector in SSP from 2008 to 2012 were pooled into the 645 municipalities of SSP. Linear regression was performed to estimate consumption levels that would have occurred in 2011 and 2012 if no law regulating OTC sales had been issued in 2010. These values were compared to actual observed levels, estimating the effect of this law. Linear regression was performed to find association of antibiotic consumption levels and of a greater effect of the law with municipality level data on SED obtained from a nationwide census. RESULTS: Oral antibiotic consumption in SSP rose from 8.44 defined daily doses per 1,000 inhabitants per day (DID) in 2008 to 9.95 in 2010, and fell to 8.06 DID in 2012. Determinants of a higher consumption were higher human development index, percentage of urban population, density of private health establishments, life expectancy and percentage of females; lower illiteracy levels and lower percentage of population between 5 and 15 years old. A higher percentage of females was associated with a stronger effect of the law. CONCLUSIONS: SSP had similar antibiotic consumption levels as the whole country of Brazil, and they were effectively reduced by the policy.

Traditional knowledge for promotion of socioeconomic inclusion of local communities / Uso do conhecimento tradicional para promover a inclusão socioeconômica de comunidades locais

This paper discusses the key role played by public research institutes for promoting socioeconomic inclusion of local communities based on traditional knowledge and traditional medicine. Nongovernmental organizations and cooperatives have had an important role in raising financial resources, being involved with advocacy of local communities and advancing legislation changes. But strict best manufacturing practices regulations imposed by the Brazilian National Health Surveillance Agency on the requirements for approval and commercialization of drugs based on herbal medicine products call for the involvement of strong public research institutes capable of supporting community-based pharmacies. Thus, public research institutes are pivotal as they can conduct scientific research studies to evidence the efficacy of herbal medicine products and help building the capacity of local communities to comply with current regulations.

O artigo mostra o papel desempenhado por institutos públicos de pesquisa no Brasil na promoção da inclusão socioeconômica de comunidades locais por meio do uso do conhecimento tradicional e da medicina popular. Organizações não-governamentais e cooperativas são importantes para angariar recursos, defender os interesses das comunidades locais e influenciar mudanças no ordenamento jurídico. Entretanto, exigências de cunho legal relacionadas às Boas Práticas de Fabricação e à necessidade de comprovação da eficácia de medicamentos, impostas pela Agência Nacional de Vigilância Sanitária, tendem a demandar a intervenção de um instituto público de pesquisa capaz de auxiliar tais comunidades na aprovação e comercialização de medicamentos produzidos a partir de plantas medicinais. Assim, institutos públicos de pesquisa são essenciais para realizar estudos científicos que comprovem a eficácia das plantas medicinais e para auxiliar as comunidades locais a criarem a infraestrutura necessária para atender às exigências da Agência quanto a Boas Práticas de Fabricação.

Traditional knowledge for promotion of socioeconomic inclusion of local communities.

This paper discusses the key role played by public research institutes for promoting socioeconomic inclusion of local communities based on traditional knowledge and traditional medicine. Nongovernmental organizations and cooperatives have had an important role in raising financial resources, being involved with advocacy of local communities and advancing legislation changes. But strict best manufacturing practices regulations imposed by the Brazilian National Health Surveillance Agency on the requirements for approval and commercialization of drugs based on herbal medicine products call for the involvement of strong public research institutes capable of supporting community-based pharmacies. Thus, public research institutes are pivotal as they can conduct scientific research studies to evidence the efficacy of herbal medicine products and help building the capacity of local communities to comply with current regulations.

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.

[Community pharmacies' professional image: causes and improvement strategies by applying qualitative research techniques]. / Imagen profesional de farmacias comunitarias: causas y estrategias de mejora aplicando técnicas de investigación cualitativa.

OBJECTIVE: Ascertaining pharmacists' views related to factors explaining the lack of visibility of community pharmacies as being health facilities and proposing strategies for improving community pharmacy professional service accessibility using qualitative research techniques. METHODS: The nominal group technique (NGT) was used in two successive rounds using separate guidelines for factors and strategies. Framework analysis was then carried out. RESULTS: Thirty-four ideas related to "factors" and 32 related to "strategies" were obtained. Strategies were grouped into 14 topics, emphasising those prioritising patient-orientated professional services, ethical aspects and pharmacists' ongoing education. DISCUSSION: The techniques used led to identifying situations perceived by pharmacists which are not formally described in the literature. Raising awareness of professional services in community pharmacies implies agreeing on and developing strategies which should be based on joint participation by the pharmacists themselves, professional associations and universities.

Imagen profesional de farmacias comunitarias: causas y estrategias de mejora aplicando técnicas de investigación cualitativa / Community pharmacies' professional image: causes and improvement strategies by applying qualitative research techniques

Objetivo Conocer las opiniones de los farmacéuticos con relación a los factores que explican la falta de visibilidad de la farmacia comunitaria como establecimiento sanitario y proponer estrategias de desarrollo profesional a fin de lograr mejorar la accesibilidad a los servicios profesionales mediante técnicas de investigación cualitativa. Material y métodos Se utilizó una Técnica de Grupo Nominal (TGN) en 2 rondas sucesivas, respondiendo a 2 consignas guía sobre factores y estrategias. Posteriormente se realizó un Framework analysis. Resultados Se aportaron 34 ideas referidas a factores y 32 a estrategias. Las estrategias fueron agrupadas en 14 temas, destacándose las vinculadas a la priorización de los servicios profesionales orientados a los pacientes, al cumplimiento de la ética y a la formación continua del farmacéutico. Discusión Las técnicas utilizadas permitieron evidenciar situaciones percibidas por los farmacéuticos que no están formalmente descriptas en la literatura. Aumentar la visibilidad de los servicios profesionales en las farmacias comunitarias implica acordar y abordar estrategias que deben sustentarse en la participación conjunta de los propios farmacéuticos, las asociaciones profesionales y las universidades.

Objective Ascertaining pharmacists' views related to factors explaining the lack of visibility of community pharmacies as being health facilities and proposing strategies for improving community pharmacy professional service accessibility using qualitative research techniques. Methods The nominal group technique (NGT) was used in two successive rounds using separate guidelines for factors and strategies. Framework analysis was then carried out. Results Thirty-four ideas related to "factors" and 32 related to "strategies" were obtained. Strategies were grouped into 14 topics, emphasising those prioritising patient-orientated professional services, ethical aspects and pharmacists' ongoing education. Discussion The techniques used led to identifying situations perceived by pharmacists which are not formally described in the literature. Raising awareness of professional services in community pharmacies implies agreeing on and developing strategies which should be based on joint participation by the pharmacists themselves, professional associations and universities.

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

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 each stratum. 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 a medical 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 unmet basic 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.

Measuring medicine prices in Peru: validation of key aspects of WHO/HAI survey methodology.

OBJECTIVES: To assess the possibility of bias due to the limited target list and geographic sampling of the World Health Organization (WHO)/Health Action International (HAI) Medicine Prices and Availability survey used in more than 70 rapid sample surveys since 2001. METHODS: A survey was conducted in Peru in 2005 using an expanded sample of medicine outlets, including remote areas. Comprehensive data were gathered on medicines in three therapeutic classes to assess the adequacy of WHO/HAI's target medicines list and the focus on only two product versions. WHO/HAI median retail prices were compared with average wholesale prices from global pharmaceutical sales data supplier IMS Health. RESULTS: No significant differences were found in overall availability or prices of target list medicines by retail location. The comprehensive survey of angiotensin-converting enzyme inhibitor, anti-diabetic, and anti-ulcer products revealed that some treatments not on the target list were costlier for patients and more likely to be unavailable, particularly in remote areas. WHO/HAI retail prices and IMS wholesale prices were strongly correlated for higher priced products, and weakly correlated for lower priced products (which had higher estimated retailer markups). CONCLUSIONS: The WHO/HAI survey approach strikes an appropriate balance between modest research costs and optimal information for policy. Focusing on commonly used medicines yields sufficient and valid results. Surveyors elsewhere should consider the limits of the survey data as well as any local circumstances, such as scarcity, that may call for extra field efforts.

Measuring medicine prices in Peru: validation of key aspects of WHO/HAI survey methodology / Determinación de los precios de los medicamentos en Perú: validación de aspectos fundamentales del método de encuesta de la OMS/HAI

Objectives: To assess the possibility of bias due to the limited target list and geographic sampling of the World Health Organization (WHO)/Health Action International (HAI) Medicine Prices and Availability survey used in more than 70 rapid sample surveys since 2001. Methods: A survey was conducted in Peru in 2005 using an expanded sample of medicine outlets, including remote areas. Comprehensive data were gathered on medicines in three therapeutic classes to assess the adequacy of WHO/HAI's target medicines list and the focus on only two product versions. WHO/HAI median retail prices were compared with average wholesale prices from global pharmaceutical sales data supplier IMS Health. Results: No significant differences were found in overall availability or prices of target list medicines by retail location. The comprehensive survey of angiotensin-converting enzyme inhibitor, anti-diabetic, and anti-ulcer products revealed that some treatments not on the target list were costlier for patients and more likely to be unavailable, particularly in remote areas. WHO/HAI retail prices and IMS wholesale prices were strongly correlated for higher priced products, and weakly correlated for lower priced products (which had higher estimated retailer markups). Conclusions: The WHO/HAI survey approach strikes an appropriate balance between modest research costs and optimal information for policy. Focusing on commonly used medicines yields sufficient and valid results. Surveyors elsewhere should consider the limits of the survey data as well as any local circumstances, such as scarcity, that may call for extra field efforts.

Objetivos: Evaluar la posibilidad de sesgo debido a la limitación de la lista de referencia y del muestreo geográfico de la encuesta de precios y disponibilidad de medicamentos de la Organización Mundial de la Salud/Health Action International (OMS/HAI) usada en más de 70 muestras de encuestas rápidas desde el 2001. Métodos: En el año 2005, se realizó una encuesta en Perú, con una muestra ampliada de puntos de venta de medicamento, incluso en zonas remotas. Se recogieron datos integrales acerca de los medicamentos de tres clases terapéuticas, con el fin de evaluar la idoneidad de la lista de referencia de medicamentos de la OMS/HAI y el énfasis únicamente en dos versiones del producto. Las medianas de los precios al por menor de la OMS/HAI se compararon con el promedio de precios al por mayor del proveedor de datos mundiales de ventas farmacéuticas IMS Health. Resultados: No se observó ninguna diferencia significativa en la disponibilidad general ni en los precios de los medicamentos de la lista de referencia por localización de venta al por menor. La encuesta integral de los inhibidores de la enzima convertidora de la angiotensina, los antidiabéticos y los productos antiulcerosos reveló que algunos tratamientos que no están en la lista destinataria eran más caros para los pacientes y era más probable que no estuvieran a la venta, sobre todo en las regiones remotas. Los precios al por menor de la OMS/HAI y los precios al por mayor de IMS presentaron una correlación intensa en el caso de los productos de precio más alto, y la correlación fue débil en el caso de los productos de precio más bajo (que tuvieron márgenes de beneficio calculados más altos para el minorista). Conclusiones: El método de la encuesta de la OMS/HAI logra un equilibrio adecuado entre los costos de investigación moderados y la información óptima para la política. El énfasis en los medicamentos de uso frecuente produce unos resultados válidos y suficientes. Los encuestadores de otros...

Potent analgesics are more expensive for patients in developing countries: a comparative study.

Opioids are some of the most important analgesic medications for the management of both moderate to severe pain and several are included on the World Health organization (WHO) list of essential drugs. Opioid costs in developing countries have been reported to be higher than those in developed nations. This study documents retail prices and availability of several potent opioids in a number of developing and developed countries. Pain and Palliative Care specialists currently working in their countries were asked to collect data on the retail cost of a 30 day supply of 15 different opioid preparations in 5 developing and 7 developed countries. Data were analyzed to compare costs and costs as a percentage of gross national product (GNP) per capita per month. Opioid costs and availability varied widely in both developing and developed countries. Forty five of 75 opioid preparations were available in developing countries (40% of medications studied were not available) and 76 of 105 preparations were available in the developed countries (28% not available). In US dollars, the median cost of opioids differed between developed and developing countries ($53 and $112 respectively) The median costs of all opioid preparations as a percentage of GNP per capita per month were 36% for developing and 3% for developed nations; the difference was statistically significant (p < 0.001). In developing countries 23 of 45 (51%) of opioid dosage forms cost more than 30% of the monthly GNP per capita, versus only three of 76 (4%) in developed countries. The relative cost of opioids to income is higher in developing countries. Our data suggest that in developing countries opioid access for the majority of patients is likely to be limited by cost, and development of palliative care programs will require heavy or total subsidization of opioid costs.

The cost-effectiveness of syndromic management in pharmacies in Lima, Peru.

BACKGROUND: Many people with sexually transmitted diseases (STDs) in Lima, Peru, seek treatment in pharmacies. GOAL: The goal was to assess the cost-effectiveness of training pharmacy workers in syndromic management of STDs. STUDY DESIGN: Cost-effectiveness from both the program and societal perspectives was determined on the basis of study costs, societal costs (cost of medicine), and the number of cases adequately managed. The latter was calculated from estimated incidence, proportion of symptomatic patients, proportion seeking treatment in pharmacies, and proportion of cases adequately managed in both comparison and intervention districts. Univariate and multivariate sensitivity analyses were performed. RESULTS: Under base-case assumptions, from the societal perspective the intervention saved an estimated US$1.51 per case adequately managed; from the program perspective, it cost an estimated US$3.67 per case adequately managed. In the sensitivity analyses, the proportion of females with vaginal discharge or pelvic inflammatory disease who seek treatment in pharmacies had the greatest impact on the estimated cost-effectiveness, along with the medication costs under the societal perspective. CONCLUSION: Training pharmacists in syndromic management of STDs appears to be cost-effective when only program costs are used and cost-saving from the societal perspective. Our methods provide a template for assessing the cost-effectiveness of managing STD syndromes, on the basis of indirect estimates of effectiveness.

Financing health care at the local level: the community drug funds of Honduras.

In response to UNICEF's Bamako Initiative, hundreds of privately run Community Drug Funds were established in Honduras during the 1990s, generally under the auspices of a non-government organization and usually with the financial assistance of international agencies. Honduras' Community Drug Funds (CDF) are rotating drug funds intended to: (1) serve as a means of increasing access to care in isolated rural populations, (2) promote the more rational use of medicines and (3) promote community participation in the financing and oversight of primary health care activities. This study is the first to analyse empirically the impact and efficiency of these institutions, relying upon primary data obtained from a survey of 51 of the 450 active CDFs in Honduras. Archival data from Ministry of Health and other sources were also analysed. The structure, operations, and impact of CDFs are detailed, with special attention given to access and quality of care issues. The study found that CDFs are rapidly becoming under-capitalized because of basic management problems, principally in pricing and in medicine purchasing practices. These shortcomings, and more generally, increasing financial pressures on NGO sponsors, are negatively affecting quality and access to care. Given the rate of erosion in CDF assets, unless they are recapitalized, the current average estimated lifespan of a CDF is 5.5 years. If these funds are to be sustainable, changes in their financing, training and supervision will be required. In addressing these issues, Honduran health policy-makers must decide how best to balance the competing goals of holding down costs, while maintaining adequate quality and improving access to care.

Comercializacion de sucedaneos de la leche materna en farmacias de la ciudad de La Paz y El Alto, 1996 / Commerce of succedaneous maternal milk in drug strores in the cities of La Paz and El Alto, 1996

El estudio muestra los resultados de una encuesta realizada en las ciudades de la Paz y El Alto, sobre comercializacion de sucedaneos de la leche materna (todo alimento comercializado o de otro modo presentado como substituto parcial o toal de la leche materna, sea o no adecuado para este fin) y alimentos complentarios (todo alimento manufacturado o preparado localmente, que convenga como complemento de la leche matrna o de las preparaciones para lactantes, cuando aquella o estas resulten insuficientes para satisfacer las necesidades nutricionales del lactante. Este tipo de alimento se suele llamar tambien "alimento de destete" o suplemento de la leche materna) en 78 farmacias de estas ciudades. Los encuestadores personificaron familiares con problemas para amamantar a su bebe, solicitando orientacion sobre acciones mas aconsejables. Preguntas tales como si es necesario visitar a un medico, suspender la lactancia materna, iniciar alimentacion con leche artificial o formula infantil, precio del sucedaneo, tiempo de administracion, producto aconsejado, edad de incio de alimentos complementarios al bebe, fueron planteadas. Se indago sobre el criterio de los responsables de farmacias sobre la utilidad o no de los estimulantes del apetito y/o vitaminas, las marcas de biberones (mamaderas) y chupones (tetinas), si ellos los recomiendan y si las leches maternizadas son saludables, sus desventajas y ventajas. Los resultados de estas interrogantes y otras se presentan y discusion en el presente articulo

Paraguayan pharmacies and the sale of pseudo-abortifacients.

This study was conducted in 1985 in Asunción, Paraguay, 6 years after the closure of the state supported family planning services. Data from national surveys in 1977 and 1987 permit a comparison of sources of contraceptive supplies before and after the elimination of government support for family planning. The purchase of pseudo-abortifacients from private pharmacies was used as an indication of induced abortion. After the loss of government clinics, it is suggested that some women turned to pharmacists to obtain pseudo-abortifacients when faced with unwanted pregnancy. There is an indication of increased pseudo-abortifacient use, particularly among unmarried women and those from poorer neighbourhoods.

PIP: The hypothesis that a restriction of family planning services will be associated with an increased incidence of abortion was investigated in a survey carried out in Asuncion, Paraguay, in 1985. In 1979, the Government of Paraguay abruptly eliminated all support for family planning services at Ministry of Health clinics--a measure that affected at least half of all contraceptive acceptors and forced them to turn to pharmacies for contraceptive supplies. The survey, which samples 10% of the registered private pharmacies in Asuncion, used the sale of pseudo- abortifacients as a measure of induced abortion. Also interviewed were 56 contraceptive purchasers and 51 purchasers of injectables contraceptives intended for use as abortifacients who were recruited at the participating pharmacies. The results indicated that low-income women were 5 times more likely than their higher income counterparts to purchase pseudo-abortifacients. In addition, unmarried women were 3 times more likely to purchase progestogen injections to induce a missed menstrual period than married women. Almost 70% of abortifacient purchasers reported that they had attempted to self-abort on previous occasions. The pharmacists stated that up to 50 women a week requested medication for pregnancy termination and were in agreement that this practice had increased substantially following the government's withdrawal of support for contraception. The pharmacists expressed concern about the nonavailability of counseling from trained family planning personnel and indicated that some pharmacy staff knowingly exploit women by injecting them with unsafe preparations or drugs that cannot induce abortion. The administration of ineffective pseudo-abortifacients can delay the decision to seek an illegal abortion or result in life-threatening incomplete abortion.