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Chagas disease constitutes a public health problem, and Spain is the non-endemic country with the highest burden of disease outside the Americas. It represents a model for non-endemic countries regarding health policies to control the disease. This study is aimed to generate estimates of the T.cruzi prevalence and the number of undetected and untreated individuals with the infection in Spain and to compare them with the actual number of cases reported by official sources.Using aggregate data collected from the literature and official sources (Spanish National Statistics Institute; Spanish Agency of Medicines and Medical Devices) from 2010 to 2018, this study estimates the number of Chagas disease cases, plus the underdiagnosis and undertreatment rates.We estimated that 55,367 out of 2,602,285 migrants originally from endemic countries were living with Chagas disease in Spain in 2018, accounting for a prevalence of 2.1%. Only 1% of these cases(613/455,566) were children aged 14 years or less resulting in a prevalence of 0.1%. Bolivian migrants accounted for 53.9% of the total estimated cases. The index of underdiagnosis and undertreatment were heterogeneous across different Spanish autonomous regions, but the overall index of underdiagnosis was around 71%, and the overall index of undertreatment was 82.5% in patients aged 15 years or older, and 60% in children.The burden of Chagas disease in Spain is considerable. Index of underdiagnosis and undertreatment are high, particularly in women of childbearing age, but they have improved in children since the implementation of antenatal screening programmes.

In the European Union multiple dose bioequivalence studies are required for the approval of generic prolonged-release products, but they are not required by the US-FDA. In order to investigate if the multiple dose bioequivalence studies are necessary, the bioequivalence studies assessed in the Spanish Agency for Medicines and Health Care Products in the last 10 years were searched to find all reasons for rejection and identify those cases where the multiple dose study had failed to show bioequivalence and the single dose study had shown bioequivalence. In these latter cases, the plasma concentration at the end of the dosing interval (C(τ)) in the single dose study was assessed to investigate its sensitivity to predict non-bioequivalence in the steady state. The search identified six cases where the non-equivalence in the multiple dose study was not detected by the corresponding single dose study. C(τ) was not able to detect the difference in five cases and in general it was more variable than conventional metrics. In conclusion, the multiple dose bioequivalence study is necessary to ensure therapeutic equivalence and the use of C(τ) would be counterproductive, increasing the sample size of the studies without enough sensitivity to detect differences in the steady state.

To analyze current legislation referring to generic drugs and to update knowledge concerning these drugs.In this paper Spanish and European regulations have been reviewed in relation to the authorisation and procedures that guarantee the quality, safety and efficacy of generics.The countries belonging to the European Union have established, through the European Medicine Agency (EMEA), uniform criteria for authorisation and data exclusivity, regulated by Directive 2004/27 and Regulation 726/2004, which are being implemented in our country through Law 29/2006 of Guaranty and Rational Use of Medicines and Medical Devices.Although mechanisms of price regulation and financing policy are different throughout the member States, most countries have introduced measures to reduce the increase in expenditure on medicines, with generic products being an important aspect since they are less expensive than innovating medicines.

To quantify the consumption of tuberculosis medication prescribed through the National Health Service in Spain during 1996. To calculate the prevalence of tuberculosis from this consumption. To analyse possible inequalities between autonomous communities. To analyse the cost of these drugs.A crossover, retrospective and observational study.Primary care.5533233 DDDs were taken in 1996. 2215890 of these DDDs belonged to the rifinah association (rifampicin + isoniazid), followed by the active principle rifampicin with 973510 DDDs. Amikacin at 8,078 DDDs represented the lowest dose. DID (dose per inhabitant per day) in Spain was 0.37. Dosage was greater in Galicia (0.66) and Ceuta (0.52). The Canaries (0.19) and Balearics (0.27) were below the national average. Use was 40.05% for rifinah, followed by 17.59% for rifampicin. The least common active principles were amikacin (0.14%) and streptomycin (0.74%). The number of cases of tubercular disease in Spain calculated was 11,211; its prevalence was 27.7 cases per 100,000 inhabitants. Total medication cost was 863275147 pesetas (0.1% of total pharmaceutical expenditure). The attributable cost was rifinah, 40.26%, the rifater association, 21.68%, and rifampicin, 18.34%.The most often prescribed drug is the rifampicin + ilsoniazid association. Use varies between autonomous communities. We think that the prevalence calculated is high for a developed country.