Legal Protection for Consumer of Pharmaceutical Products

The overall focus of the thesis involves the legal protection for consumers of pharmaceutical products.The work on “Legal Protection for Consumers of Pharmaceutical Products” is undertaken to study the legal framework that is existing for this purpose and the functioning of regulating mechanism that is envisaged under it. The purpose of the study is to analyse how far these measures are effective in adequately protecting various aspects of consumer interest. Methodology adopted for the study is analytical.The present study revealed that the theory of freedom of contract is only an ideal relevant when the parties are assumed to be on equal footing.In a more complicated social and economic society, it ceased to have any relevance. Many countries in the world enacted legislations to protect the consumers of pharmaceutical products.The meaning of ‘consumers of drugs’ provided in the law is inclusive and not exhaustive one. The definition of ‘drug’ as interpreted by the courts is comprehensive enough to take in it not only medicines but also substances. The meaning of the word substances has been widened by the interpretation of the courts so as to include all the things used in treatment.The definition of the word ‘consumer’ has been liberally interpreted by the courts so as to provide protective net to a large section of the public.The studies subsequent to this report also revealed that there is a shortage of essential drugs necessary to cure local diseases like tuberculosis and malaria where as drugs containing vitamins and other combinations which are more profitable for the manufacturers are produced and marketed in abundance.The study of the provisions in this regard revealed that the duty of the drug controlling authorities is confined to scrutinize the data of the clinical test already conducted by the sponsor of the drug.Study of the clinical trial procedure under the U.S. law revealed that there is a continuous supervision over clinical trials and controls are provided on the treatment use of an investigational productStudy of the clinical trial procedure under the U.S. law revealed that there is a continuous supervision over clinical trials and controls are provided on the treatment use of an investigational product.the study of the provisions of the Drugs and Cosmetics Act and the rules framed under it revealed that the law in this regard is comprehensive to protect the consumer provided it is sufficiently supported by adequately equipped enforcement machinery.

Grado de pérdida de capacidad laboral asociada a la comorbilidad de los desórdenes músculo esqueléticos en la junta de calificación de invalidez regional Huila, 2009-2012

Resumen: Los desórdenes músculo esqueléticos son entidades que generan un efecto en la salud relacionados con la calidad de vida, dado al impacto global en la condición física, el bienestar psicológico y funcional. Estas entidades generan un gran número de indemnizaciones y en algunas oportunidades según el grado de pérdida de capacidad laboral la invalidez. Objetivo: Determinar la asociación del grado de perdida de la capacidad laboral con la comorbilidad de los desórdenes músculo esqueléticos y otros factores asociados. Materiales y métodos: Se realizó un estudio de corte transversal, basado en registros e historias clínicas. Los registros iniciales fueron 1427 casos, de los cuales 513 presentaban diagnóstico de DME y de estos 240 solicitaron la pérdida de capacidad laboral a la junta de invalidez regional Huila en el periodo comprendido del 2009 al 2012. Resultados: La distribución del grado de la pérdida de capacidad laboral generada de los DME por incapacidad permanente parcial fue del 73,3% y por invalidez el 26,7%. Se encontró una asociación significativa con respecto a la edad (p=0,002), donde el rango de 50-65 años presento mayor pérdida de capacidad laboral; con el género (p=0,047), siendo el femenino más prevalente la invalidez (34,7%) que en el masculino (23,2%) y la comorbilidad (p=0,019), donde los desórdenes músculo esqueléticos y los trastornos depresivos generaron mayor pérdida de capacidad laboral. No se encontró asociación significativa con la escolaridad (p=0,167), oficio (p=0,442) y actividad económica (p=0,118). En el análisis multivariado se encontró asociación significativa con el origen común (OR=4.028, IC 95%: 2.010, 8.072), el sexo femenino (OR=2.565, IC 95%: 1.140, 5.771), y el nivel de escolaridad técnico (OR=12.208, IC 95%: 1.372, 108.634). Conclusiones: La comorbilidad generó mayor pérdida de capacidad laboral, aunque los factores que en conjunto mostraron asociación fueron la edad avanzada, el género femenino, el origen común y el menor nivel educativo.

Alcances y desafíos del proceso de hermanamiento “Sister Cities" desarrollado por la ciudad de Santa Marta en el marco de su proceso de internacionalización: 1978- 2013.

La evolución de los enfoques de la cooperación internacional y de los procesos de internacionalización de las ciudades han contribuido activamente al desarrollo territorial. Los hermanamientos como una herramienta clave para el intercambio social, político, económico, técnico y académico entre ciudades, se han convertido en uno de los métodos más utilizados para el accionar internacional. Bajo ese contexto, se analizará la influencia del proceso de internacionalización de Santa Marta en la implementación del hermanamiento “Sister Cities” con Miami Beach. Lo anterior, pretende demostrar que el proceso de internacionalización de la ciudad de Santa Marta, desde 1989 hasta la actualidad, ha influido directamente en el hermanamiento entre las dos ciudades, obviando oportunidades y beneficios. Finalmente, a partir del resultado de la investigación se sugerirá una alternativa de solución para la optimización del acuerdo entre las dos ciudades.

Potassium leaching in undisturbed soil cores following surface applications of gypsum

Displacement studies on leaching of potassium (K+) were conducted under unsaturated steady state flow conditions in nine undisturbed soil columns (15.5 cm in diameter and 25 cm long). Pulses of K+ applied to columns of undisturbed soil were leached with distilled water or calcium chloride (CaCl2) at a rate of 18 mm h(-1). The movement of K+ in gypsum treated soil leached with distilled water was at a similar rate to that of the untreated soil leached with 15 mM CaCl2. The Ca2+ concentrations in the leachates were about 15 mM, the expected values for the dissolution of the gypsum. When applied K+ was displaced with the distilled water, K+ was retained in the top 10-12.5 cm depth of soil. In the undisturbed soil cores there is possibility of preferential flow and lack of K+ sorption. The application of gypsum and CaCl2 in the reclamation of sodic soils would be expected to leach K+ from soils. It can also be concluded that the use of sources of water for irrigation which have a high Ca2+ concentration can also lead to leaching of K+ from soil. Average effluent concentration of K+ during leaching period was 30.2 and 28.6 mg l(-1) for the gypsum and CaCl2 treated soils, respectively. These concentrations are greater than the recommended guideline of the World Health Organisation (12 mg K+ l(-1)).

Anti-cancer properties of phenolics from apple waste on colon carcinogenesis in vitro

Colorectal cancer is one of the most common cancers in Western countries. The World Health Organisation identifies diet as a critical risk factor in the development and progression of this disease and the protective role of high levels of fruit and vegetable consumption. Several studies have shown that apples contain several phenolic compounds that are potent anti-oxidants in humans. However, little is known about other beneficial properties of apple phenolics in cancer. We have used the HT29, HT115 and CaCo-2 cell lines as in vitro models to examine the effect of apple phenolics (0.01–0.1% apple extract) on key stages of colorectal carcinogenesis, namely; DNA damage (Comet assay), colonic barrier function (TER assay), cell cycle progression (DNA content assay) and invasion (Matrigel assay). Our results indicate that a crude extract of apple phenolics can protect against DNA damage, improve barrier function and inhibit invasion (p < 0.05). The anti-invasive effects of the extract were enhanced with twenty-four hour pretreatment of cells (p < 0.05). We have shown that a crude apple extract from waste, rich in phenolic compounds, beneficially influences key stages of carcinogenesis in colon cells in vitro.

Simplified follow-up after medical abortion using a low-sensitivity urinary pregnancy test and a pictorial instruction sheet in Rajasthan, India : study protocol and intervention adaptation of a randomised control trial

The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion, among women as well as providers. It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic. Trial design The study is a randomised, controlled, non-superiority trial . Methods Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home, while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor. The primary objective of the study is to evaluate the effectiveness of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion. Providers or research assistants will not be blinded during outcome assessment. To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation. This was to optimise and tailor-make the intervention and the study procedures and resulted in the development of the pictorial instruction sheet for how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion. Discussion In this paper, we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment, 10-14 days after a medical abortion. Moreover, a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor. Trial registration: Clinicaltrials.gov NCT01827995. Registered 04 May 2013

Med rena händer i kampen mot VRI : Sjuksköterskors följsamhet till riktlinjer om handhygien: främjande och hindrande faktorer En litteraturöversikt

Bakgrund: Uppkomsten av vårdrelaterade infektioner (VRI) är ett globalt problem. Den vanligaste smittvägen är via personalens händer. Bra handhygien är väsentligt för att minska VRI. Med bättre följsamhet till handhygien kan uppkomsten av VRI minskas, därför har forskning om följsamhet till handhygien och faktorer som inverkar, stort betydelse. Syfte: Syftet var att sammanställa och beskriva aktuell forskning om sjuksköterskors följsamhet till handhygien och vilka faktorer främjar respektive hindrar följsamheten till handhygien. Metod: En litteraturöversikt som baserades på artiklar publicerade de senaste fem åren, från länder som följer Världshälsoorganisationens (WHO) handhygieniska riktlinjer. Sexton artiklar valdes efter kvalitetsgranskning för analys och beskrivning. Artiklarna bearbetades med innehållsanalys. Resultat: Sjuksköterskors följsamhet till handhygien var låg. Följande främjande faktorer identifierades: handhygien efter patientkontakt, materialtillgång, förebilder, utbildning, verbala och visuella påminnelser, positiva individuella attityder, kvinnlig könstillhörighet, yrkesgrupp, specialitet, patientens skydd, arbetskultur och samhällets inställning till handhygien. Följande hindrande faktorer identifierades: hög arbetsbelastning, bristande utbildning, kunskapsbrist, individuella attityder, hudpåverkan, materialtillgång, arbetskultur och samhällets inställning till handhygien, manlig könstillhörighet, yrkesgrupp, specialitet. Slutsats: Enligt resultat rekommenderas: samspelet med kollegor och patienter, stöd av teamarbete ledare, förebilder, materialtillgång, utbildning, påminnelser, intervention med tillgång till information, stöd, resurser och möjligheter för regelbunden kunskapsuppföljning, motivera till handhygien före patientkontakt, involvera patienter.

Acupuntura: bases científicas e aplicações

A acupuntura visa à terapia e à cura das enfermidades pela aplicação de estímulos através da pele, com a inserção de agulhas em pontos específicos. Essa técnica esteve isolada do mundo ocidental durante milênios, distanciando sua forma de raciocínio e linguagem da cultura ocidental. Isto restringe sua aceitação no Ocidente, sendo considerada mística e sem base científica. Além disso, a prática da acupuntura no Ocidente se depara com deficiências no ensino e difusão científica. Porém, a eficácia dessa terapia levou a Organização Mundial de Saúde a listar enfermidades que podem ser tratadas pela acupuntura e, recentemente, essa técnica foi reconhecida como especialidade médica veterinária no Brasil. A pesquisa da acupuntura reveste-se, portanto, de grande interesse, na medida em que poderá traduzir conhecimentos milenares, contribuindo para sua aceitação e incorporação.

Fitoterapia no sistema de saúde pública (SUS) no Estado de São Paulo, Brasil

Phytotherapy is a form of familiar treatment throughout the world and recommended by the World Health Organisation to be used in all regions, especially in the poorer countries, to improve the state of health of their people. The aim of this study was to describe the use of herbal medicine as an alternative therapy in the public health system in Sao Paulo State. The fieldwork consisted in obtaining information, from all the Regional Health Authorities in the State, about which municipal health areas use this therapy and sending them a questionnaire requesting details about the application of phitotherapy: when the therapy had been adopted, which plants were used, whether the programme had been discontinued or not and if so, for what reason. The cities that use the phytotherapy are: Campinas; Canas; Guaratingueta; Herculandia; Piquete; Pindamonhangaba; Roseira e Sao Jose do Barreiro, Ribeirao Preto, Sao Lourenço da Serra, Cruzeiro e Dobrada. And the three plant more used are: Guaco (Mikania glomerate); Calendula (Calendula officinalis) e Babosa (Aloe vera) The lack of support has led some Authorities to discontinue their active in 08 programmes. Nevertheless, it is concluded that the efficacy and low cost of herbal treatments has engendered a growing interest among health professionals in placing proposals for implanting this therapy in 13 cities in the Municipal Health. Thus, there should be growing practical support for the establishment of such programmes in the future.

Fontes e composição das partículas atmosféricas na área urbana e rural da região central do Estado de São Paulo

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Avaliação da atenção concentrada e memória em tabagistas com baixa carga tabágica

Introduction: Smoking is considered by World Health Organisation (WHO) a disease, since nicotine is addictive and cause physical, emotional and behavioral disorders in people who smoke. The objective of this study was to evaluate the concentrated attention and memory in smokers and nonsmokers, and the influence of one cigarette in this variables. Material and Methods: We selected two groups of subjects between 18 and 25 years, with no history of acute or chronic respiratory disease. Group 1 (G1) consist of 40 nonsmoking individuals and group 2 (G2) 40 smokers (who smoked less than 20 cigarettes per day, for up to 10 years). The subjects were tested for concentrated attention and memory test (AC Test), nonsmokers performed the test once, smokers performed the test twice, before smoking and after five minutes after smoking one cigarette. Smokers stayed without cigarret for one our before the first test. Results: Comparing the tests nonsmokers versus smokers first test, there was no significant difference (p> 0.05), however, the analysis of the two trials of smokers, showed improvement in concentrated attention and memory after smoke (p <0.0001). Conclusions: There was no difference in Concentrated Attention and Memory among nonsmokers and smokers in abstinence, however smokers showed significant improvement in AC Test after smoking.

Classification of histological images based on the stationary wavelet transform

Non-Hodgkin lymphomas are of many distinct types, and different classification systems make it difficult to diagnose them correctly. Many of these systems classify lymphomas only based on what they look like under a microscope. In 2008 the World Health Organisation (WHO) introduced the most recent system, which also considers the chromosome features of the lymphoma cells and the presence of certain proteins on their surface. The WHO system is the one that we apply in this work. Herewith we present an automatic method to classify histological images of three types of non-Hodgkin lymphoma. Our method is based on the Stationary Wavelet Transform (SWT), and it consists of three steps: 1) extracting sub-bands from the histological image through SWT, 2) applying Analysis of Variance (ANOVA) to clean noise and select the most relevant information, 3) classifying it by the Support Vector Machine (SVM) algorithm. The kernel types Linear, RBF and Polynomial were evaluated with our method applied to 210 images of lymphoma from the National Institute on Aging. We concluded that the following combination led to the most relevant results: detail sub-band, ANOVA and SVM with Linear and RBF kernels.

Cross-national differences in questionnaires do not necessarily reflect comparable differences in disorder prevalence

To examine whether the widely used Strengths and Difficulties Questionnaire (SDQ) can validly be used to compare the prevalence of child mental health problems cross nationally. We used data on 29,225 5- to 16-year olds in eight population-based studies from seven countries: Bangladesh, Brazil, Britain, India, Norway, Russia and Yemen. Parents completed the SDQ in all eight studies, teachers in seven studies and youth in five studies. We used these SDQ data to calculate three different sorts of "caseness indicators" based on (1) SDQ symptoms, (2) SDQ symptoms plus impact and (3) an overall respondent judgement of 'definite' or 'severe' difficulties. Respondents also completed structured diagnostic interviews including extensive open-ended questions (the Development and Well-Being Assessment, DAWBA). Diagnostic ratings were all carried out or supervised by the DAWBA's creator, working in conjunction with experienced local professionals. As judged by the DAWBA, the prevalence of any mental disorder ranged from 2.2% in India to 17.1% in Russia. The nine SDQ caseness indicators (three indicators times three informants) explained 8-56% of the cross-national variation in disorder prevalence. This was insufficient to make meaningful prevalence estimates since populations with a similar measured prevalence of disorder on the DAWBA showed large variations across the various SDQ caseness indicators. The relationship between SDQ caseness indicators and disorder rates varies substantially between populations: cross-national differences in SDQ indicators do not necessarily reflect comparable differences in disorder rates. More generally, considerable caution is required when interpreting cross-cultural comparisons of mental health, particularly when these rely on brief questionnaires.

Genetic relatedness of Plasmodium falciparum isolates and the origin of allelic diversity at the merozoite surface protein-1 (MSP-1) locus in Brazil and Vietnam

Abstract Background Despite the extensive polymorphism at the merozoite surface protein-1 (MSP-1) locus of Plasmodium falciparum, that encodes a major repetitive malaria vaccine candidate antigen, identical and nearly identical alleles frequently occur in sympatric parasites. Here we used microsatellite haplotyping to estimate the genetic distance between isolates carrying identical and nearly identical MSP-1 alleles. Methods We analyzed 28 isolates from hypoendemic areas in north-western Brazil, collected between 1985 and 1998, and 23 isolates obtained in mesoendemic southern Vietnam in 1996. MSP-1 alleles were characterized by combining PCR typing with allele-specific primers and partial DNA sequencing. The following single-copy microsatellite markers were typed : Polyα, TA42 (only for Brazilian samples), TA81, TA1, TA87, TA109 (only for Brazilian samples), 2490, ARAII, PfG377, PfPK2, and TA60. Results The low pair-wise average genetic distance between microsatellite haplotypes of isolates sharing identical MSP-1 alleles indicates that epidemic propagation of discrete parasite clones originated most identical MSP-1 alleles in parasite populations from Brazil and Vietnam. At least one epidemic clone propagating in Brazil remained relatively unchanged over more than one decade. Moreover, we found no evidence that rearrangements of MSP-1 repeats, putatively created by mitotic recombination events, generated new alleles within clonal lineages of parasites in either country. Conclusion Identical MSP-1 alleles originated from co-ancestry in both populations, whereas nearly identical MSP-1 alleles have probably appeared independently in unrelated parasite lineages.

Treatment response of cystic echinococcosis to benzimidazoles: a systematic review

Over the past 30 years, benzimidazoles have increasingly been used to treat cystic echinococcosis (CE). The efficacy of benzimidazoles, however, remains unclear. We systematically searched MEDLINE, EMBASE, SIGLE, and CCTR to identify studies on benzimidazole treatment outcome. A large heterogeneity of methods in 23 reports precluded a meta-analysis of published results. Specialist centres were contacted to provide individual patient data. We conducted survival analyses for cyst response defined as inactive (CE4 or CE5 by the ultrasound-based World Health Organisation [WHO] classification scheme) or as disappeared. We collected data from 711 treated patients with 1,308 cysts from six centres (five countries). Analysis was restricted to 1,159 liver and peritoneal cysts. Overall, 1-2 y after initiation of benzimidazole treatment 50%-75% of active C1 cysts were classified as inactive/disappeared compared to 30%-55% of CE2 and CE3 cysts. Further in analyzing the rate of inactivation/disappearance with regard to cyst size, 50%-60% of cysts <6 cm responded to treatment after 1-2 y compared to 25%-50% of cysts >6 cm. However, 25% of cysts reverted to active status within 1.5 to 2 y after having initially responded and multiple relapses were observed; after the second and third treatment 60% of cysts relapsed within 2 y. We estimated that 2 y after treatment initiation 40% of cysts are still active or become active again. The overall efficacy of benzimidazoles has been overstated in the past. There is an urgent need for a pragmatic randomised controlled trial that compares standardized benzimidazole therapy on responsive cyst stages with the other treatment modalities.