Impact on In- and Out-of-Hospital Drug Prescriptions of Including a More Expensive Me-Too Antidepressant in a Hospital Drug Formulary: a Controlled Longitudinal Study.

BACKGROUND: The effect of the inclusion of a more expensive me-too medicine in a hospital drug formulary (HDF) on both in- and out-of-hospital utilization, and the contextual factors which influence this type of induction is rarely studied. Accordingly, this work aimed to quantify the effect of the decision of a hospital of including a more expensive me-too antidepressant in its HDF. METHODS: A controlled longitudinal study was carried out in a Regional Health Service of Spain. We performed a segmented regression analysis with control group. We used the following dependent variables: defined daily doses (DDD) per 1000 inhabitants per day, DDD per 100 bed days, and cost per DDD. RESULTS: At a hospital level, the modification in the formulary led to utilization changes: (1) an increase in immediate consumption of the newly included me-too drug; and, (2) an annual 25.96% [95% CI: 2.96%-48.95%] decrease in the adjusted trend of the already existing parent antidepressant. The adjusted trend of the cost per DDD of the sum of all medications in the therapeutic group increased by 20.03% annually [95% CI: 3.24%-36.82%]. In the out-of-hospital setting utilization changes were: (1) the adjusted trend of the newly included me-too drug rose by 12.14% annually [95% CI: 4.97%-19.30%]; and, (2) that of the parent drug underwent a negative change in trend of 4.18% annually [95% CI: 0.00%-8.36%]. CONCLUSIONS: The inclusion of a more expensive me-too drug in the HDF led to increased consumption of this more expensive me-too drug both in- and out-of-hospital.

Impact of a health alert and its implementation on flutamide prescriptions for women: an interrupted time series analysis.

BACKGROUND: Off-label drug use among ambulatory patients is often based on little or no scientific support. This paper reports the impact of a health warning about the risks of off-label flutamide use by women and the actions subsequently implemented by the public health service targeting such use. METHOD: The study was undertaken in a region in north-west Spain. We designed a segmented regression model of an interrupted time series, in which the dependent variable was the monthly value of defined daily doses of flutamide per 1000 inhabitants/day (DDD/TID), both total and stratified by sex. The following two data sources were used: flutamide prescriptions billed to the Spanish National Health Service; and flutamide deliveries made by wholesale drug distributors to pharmacies. The intervention assessed consisted of the issue of an official health warning and the actions subsequently taken to implement it. RESULTS: There was an immediate reduction of 49.33% in DDD/TID billed to the Spanish National Health Service in respect of women; the mean value of the population percentage of DDD/TID of flutamide billed in respect of women fell from 34.4% pre-intervention to 23.72% post-intervention. There was an immediate reduction of 19.92% (95%CI: 6.68-33.15%) in total DDD/TID invoiced. There were no significant changes in DDD/TID billed in respect of men or in flutamide use in the private medical sector. CONCLUSIONS: Off-label drug misuse is a reality among ambulatory patients, even after actions are implemented following a toxicity warning issued by the competent Health Authority.

Impact of a change of bronchodilator medications in a hospital drug formulary on intra- and out-of-hospital drug prescriptions: interrupted time series design with comparison group.

BACKGROUND: Hospital drug formularies are reduced lists of drugs designed to optimise inpatient care. Adherence to the drugs included in such formularies is not always 100% but is generally very high. Little research has targeted the impact of a change in these formularies on outpatient drug prescriptions. This study therefore sought to evaluate the impact of a change affecting bronchodilator medications in a hospital drug formulary on intra- and out-of-hospital drug prescriptions in a region in north-western Spain. Two new drugs belonging to this same class were brought onto the out-of-hospital market, overlapping with the intervention. METHODS: We used a natural before-after quasi-experimental design with control group based on monthly data. The intervention evaluated was the modification of a hospital drug formulary, which involved withdrawing salmeterol/fluticasone in order to retain formoterol/budesonide as the sole inhaled corticosteroid and long-acting beta-agonist (ICS/LABA). Using official data sources, we extracted the following dependent variables: defined daily doses (DDD) per 1000 inhabitants per day, DDD per 100 bed-days, and cost per DDD. RESULTS: Intra-hospital use showed a 173.2% rise (95% CI 47.3-299.0%) in the medication retained in the formulary, formoterol/budesonide, and a 94.9% drop (95% CI 77.9-111.9%) in the medication withdrawn from the formulary, salmeterol/fluticasone. This intervention led to an immediate reduction of 75.9% (95% CI 82.8-68.9%) in the intra-hospital cost per DDD of ICS/LABA. No significant changes were observed in out-of-hospital use. CONCLUSIONS: Although this intervention was cost-effective in the intra-hospital setting, the out-of-hospital impact of a change in the drug formulary cannot be generalised to all types of medications and situations.

Impact of removal and restriction of me-too medicines in a hospital drug formulary on in- and outpatient drug prescriptions: interrupted time series design with comparison group.

BACKGROUND: The study covered in- and out-of-hospital care in a region in north-western Spain. The intervention evaluated took the form of a change in the hospital drugs formulary. Before the intervention, the formulary contained four of the five low molecular weight heparins (LMWHs) marketed in Spain. The intervention consisted of withdrawing two LMWHs (bemiparin and dalteparin) from the formulary and restricting the use of another (tinzaparin), leaving only enoxaparin as an unrestricted prescription LMWH. Accordingly, the aim of this study was to evaluate the effect on in- and outpatient drug prescriptions of removing and restricting the use of several LMWHs in a hospital drugs formulary. METHODS: We used a natural, before-after, quasi-experimental design with a control group and monthly data from January 2011 to December 2016. Based on data drawn from official Public Health Service sources, the following dependent variables were extracted: defined daily doses (DDD) per 1000 inhabitants per day (DDD/TID), DDD per 100 stays per day, and expenditure per DDD. RESULTS: The two compounds that were removed from the formulary registered an immediate decrease at both an intra- and out-of-hospital level (66.6% and 55.6% for bemiparin and 73.0% and 92.2% for dalteparin, respectively); similarly, the compound that was restricted also registered an immediate decrease (36.1% and 9.0% at the in- and outpatient levels, respectively); in contrast, the remaining LMWH (enoxaparin) registered an immediate, significant increase at both levels (44.9% and 32.6%, respectively). The intervention led to an immediate reduction of 6.8% and a change in trend in out-of-hospital cost/DDD; it also avoided an expenditure of €477,317.1 in the 21 months following the intervention. CONCLUSIONS: The results indicate that changes made in a hospital drugs formulary towards more efficient medications may lead to better use of pharmacotherapeutic resources in its health catchment area.

Impact of Health Authority Control Measures Aimed at Reducing the Illicit Use of Anabolic-Androgenic Steroids.

OBJECTIVE: To evaluate two interventions on anabolic-androgenic-steroids (AAS) dispensation in retail pharmacies. MATERIAL AND METHODS: The study was conducted in a north-western region of Spain. Data were the AAS supplied by wholesale drug distributors to retail pharmacies over a period of 102 months. It is designed as an ecological time-series study; the dependent variables were daily defined doses per 1,000 inhabitants per day of each drug. The two interventions evaluated were: (1) an inspection program intended for those retail pharmacies where there was an irregular dispensation and (2) a regulation put forth forcing these pharmacies to carry out additional registers. The medications studied were stanozolol, nandrolone, methenolone, testosterone and mesterolone. RESULTS: The pre-intervention use of AAS displayed a rising trend. There was an immediate reduction of 30.56% after the first intervention, and a further reduction of 35.25% after the second. There was a seasonal pattern of use in the pre-intervention period, pointing to an increased demand at the end of spring and beginning of summer. The most abused drugs were stanozolol and nandrolone. CONCLUSION: The health actions were very effective, in that they brought about a sharp reduction in the illicit use of AAS. These interventions could be applied to other drugs in which abuse were detected.

The influence of changes in hospital drug formulary on the prescription of proton pump inhibitors / Influencia del cambio de la guía farmacoterapéutica hospitalaria en la prescripción de inhibidores de la bomba de protones

Objective: To analyze the impact of introducing omeprazole in the drug formulary of the Hospital de Barbanza on prescriptions made in hospital and out-of-hospital (Outpatient Units and Primary Care) for all Proton Pump Inhibitors (PPIs). Material and methods: A 36-month retrospective descriptive study in a level I hospital. The basic units of work are Dose-Population-Day in the outpatient setting, and the Defined Daily Dose/stays-day for hospitalized patients; the proportion of DDDs for omeprazole vs. the rest of PPIs is used as measure of efficiency. For statistical analysis, we built a segmented regression model. Results: In the outpatient units, there are statistically significant changes for pantoprazole and rabeprazole. The first drug, which was stable before the intervention, suffered an immediate decrease; rabeprazole, which was increasing before the intervention, presented a subsequent downward trend. In Primary Care, a statistically significant change was confirmed for pantoprazole, with a long-term decreasing trend. In hospitalization, statistically significant changes were observed for pantoprazole and omeprazole; the first one with an immediate decrease and a long-term tendency to decrease, while omeprazole experienced an immediate increase and long-term growth. The evolution of the omeprazole percentage vs. all PPIs showed increases in all three scenarios. Conclusions: A shift to a more efficient prescription of PPIs was observed in all healthcare settings following the introduction of omeprazole in the hospital drug formulary. The inclusion of efficient drugs, or the removal of those inefficient, can be a potentially useful tool in order to improve prescription profiles (AU)

Objetivo: Analizar el impacto de introducir el omeprazol en el formulario del Hospital de Barbanza sobre las prescripciones intrahospitalarias y extrahospitalarias (consultas externas y atención primaria) de todos los Inhibidores de la Bomba de Protones (IBP). Material y métodos: Estudio descriptivo retrospectivo de 36 meses en un hospital de nivel I. Las unidades básicas de trabajo son las dosis-habitantes-día en el ámbito extrahospitalario y las dosis diarias definidas/estancias-día para hospitalización; como medida de eficiencia se utiliza el porcentaje de DDD de omeprazol sobre el resto de IBP. Para el análisis estadístico construimos un modelo de regresión segmentada. Resultados: En consultas externas sufren cambios estadísticamente significativos el pantoprazol y el rabeprazol; el primero, estacionado antes de la intervención, sufre una disminución inmediata; el rabeprazol, en crecimiento antes de la intervención, presenta una posterior tendencia decreciente. En atención primaria se constata un cambio estadísticamente significativo en el pantoprazol, con tendencia decreciente a largo plazo. En hospitalización se observan cambios estadísticamente significativos para el pantoprazol y el omeprazol; el primero con disminución inmediata y tendencia al decrecimiento a largo plazo; el segundo experimenta un aumento inmediato y crecimiento a largo plazo. La evolución del % de omeprazol respecto al total de IBP mostró aumentos en los tres escenarios. Conclusiones: Se observa un cambio hacia una prescripción de IBP más eficiente en todos los ámbitos asistenciales tras la introducción del omeprazol en la guía farmacoterapéutica de hospital. La inclusión de medicamentos eficientes, o la retirada de ineficientes, puede ser una herramienta potencialmente útil para mejorar los perfiles de prescripción (AU)

The influence of changes in hospital drug formulary on the prescription of proton pump inhibitors.

OBJECTIVE: To analyze the impact of introducing omeprazole in the drug formulary of the Hospital de Barbanza on prescriptions made in hospital and out-of-hospital (Outpatient Units and Primary Care) for all Proton Pump Inhibitors (PPIs). MATERIAL AND METHODS: A 36-month retrospective descriptive study in a level I hospital. The basic units of work are Dose-Population- Day in the outpatient setting, and the Defined Daily Dose/stays-day for hospitalized patients; the proportion of DDDs for omeprazole vs. the rest of PPIs is used as measure of efficiency. For statistical analysis, we built a segmented regression model. RESULTS: In the outpatient units, there are statistically significant changes for pantoprazole and rabeprazole. The first drug, which was stable before the intervention, suffered an immediate decrease; rabeprazole, which was increasing before the intervention, presented a subsequent downward trend. In Primary Care, a statistically significant change was confirmed for pantoprazole, with a long-term decreasing trend. In hospitalization, statistically significant changes were observed for pantoprazole and omeprazole; the first one with an immediate decrease and a long-term tendency to decrease, while omeprazole experienced an immediate increase and long-term growth. The evolution of the omeprazole percentage vs. all PPIs showed increases in all three scenarios. CONCLUSIONS: A shift to a more efficient prescription of PPIs was observed in all healthcare settings following the introduction of omeprazole in the hospital drug formulary. The inclusion of efficient drugs, or the removal of those inefficient, can be a potentially useful tool in order to improve prescription profiles.

Objetivo: Analizar el impacto de introducir el omeprazol en el formulario del Hospital de Barbanza sobre las prescripciones intrahospitalarias y extrahospitalarias (consultas externas y atención primaria) de todos los Inhibidores de la Bomba de Protones (IBP). Material y métodos: Estudio descriptivo retrospectivo de 36 meses en un hospital de nivel I. Las unidades básicas de trabajo son las dosis-habitantes-día en el ámbito extrahospitalario y las dosis diarias definidas/estancias-día para hospitalización; como medida de eficiencia se utiliza el porcentaje de DDD de omeprazol sobre el resto de IBP. Para el análisis estadístico construimos un modelo de regresión segmentada. Resultados: En consultas externas sufren cambios estadísticamente significativos el pantoprazol y el rabeprazol; el primero, estacionado antes de la intervención, sufre una disminución inmediata; el rabeprazol, en crecimiento antes de la intervención, presenta una posterior tendencia decreciente. En atención primaria se constata un cambio estadísticamente significativo en el pantoprazol, con tendencia decreciente a largo plazo. En hospitalización se observan cambios estadísticamente significativos para el pantoprazol y el omeprazol; el primero con disminución inmediata y tendencia al decrecimiento a largo plazo; el segundo experimenta un aumento inmediato y crecimiento a largo plazo. La evolución del % de omeprazol respecto al total de IBP mostró aumentos en los tres escenarios. Conclusiones: Se observa un cambio hacia una prescripción de IBP más eficiente en todos los ámbitos asistenciales tras la introducción del omeprazol en la guía farmacoterapéutica del hospital. La inclusión de medicamentos eficientes, o la retirada de ineficientes, puede ser una herramienta potencialmente útil para mejorar los perfiles de prescripción.

¿Tenemos presente en las instituciones sanitarias el consumo indebido de medicamentos con fines de dopaje? / Are health institutions aware of the misuse of drugs for doping purposes?

No disponible

[Methodology for Identification of Inverse Drug Distribution, Spain]. / Resultados de una metodología para la identificación de distribución inversa de medicamentos en oficinas de farmacia.

OBJECTIVE: The phenomenon of reverse drug trafficking in the legal supply chain is an unlawful practice to serious risks to public health. The aims was to identify proactively pharmacies that carry out these illegal activities. METHODS: An analysis was performed through the crossing billing data to SAS of 52 million packs of medicines for the 496 pharmacies in the province over a period of 29 months with the drug packaging data supplied by the distribution entities of the province with the implementation of specific indicator defined called 'percentage overbought' allows us to detect those pharmacies at high risk of being involved in this illicit trade. RESULTS: It was tested in two pharmacies one rural and other urban a detour of 5.130 medicine containers and an illicit profit obtained from € 9,591.78 for the first and 9.982 packaging and € 26,885.11 for the second; they had gone unnoticed in previous inspections. CONCLUSIONS: The methodology implemented to define a profile of infringing pharmacies high risk in these illicit practices, identify new ones that had not been sanctioned, weigh the drugs for illegal trade and to identify new drugs subject to diversion; also added as a challenge, it helps to adjust accurately and effectively calculate the illicit profit obtained.

OBJETIVO: El fenómeno del tráfico inverso en la cadena legal de suministro de medicamentos es una práctica ilícita con graves riesgos para la Salud Pública. El objetivo de este trabajo fue identificar de forma proactiva las oficinas de farmacia que realizan estas conductas ilegales. METODOS: Se cruzaron los datos de facturación al SAS de 52 millones de envases de medicamentos con los de las 496 farmacias de la provincia en un periodo de 29 meses (abril de 2012 a agosto de 2014). Junto con la aplicación del indicador específico definido denominado "porcentaje de sobrecompra", permitió identificar los establecimientos farmacéuticos con alto riesgo de estar implicados en el comercio ilícito. RESULTADOS: Se comprobó que hubo desvío en dos oficinas de farmacia, una rural (de 5.130 envases de medicamentos y beneficio ilícito obtenido de 9.591,78 €) y otra urbana (9.982 envases y 26.885,11 €), los cuales habían pasado desapercibidos en anteriores actuaciones inspectoras. CONCLUSIONES: La metodología implantada permite definir un perfil de oficina de farmacia infractora de alto riesgo en estas prácticas ilícitas, identificarlas, ponderar los fármacos destinados a este comercio ilegal y determinar nuevos medicamentos objeto de desvío. Ayuda a ajustar de forma precisa el cálculo del beneficio ilícito obtenido.

Eficiencia del programa de seguimiento farmacoterapéutico de antipsicóticos parenterales de acción prolongada en el área sanitaria de Santiago de Compostela / Efficiency of a pharmaceutical care program for long-acting parenteral antipsychotics in the health area of Santiago de Compostela

En el área sanitaria de Santiago de Compostela, el subgrupo terapéutico "otros antipsicóticos" era el quinto en mayor gasto extrahospitalario en el año 2013, correspondiendo más de la mitad a la risperidona y paliperidona parenterales de acción prolongada. La implantación de un programa de seguimiento farmacoterapéutico basado en la gestión por procesos y en la coordinación de actuaciones entre profesionales sanitarios de ambos niveles asistenciales supuso, en 12 meses un ahorro para la organización de 636.391,01 €, para el paciente de 16.767,36 € en aportaciones y 9.008 desplazamientos a la oficina de farmacia. Este trabajo muestra la eficiencia del programa facilitado por tratarse de un área de gestión integrada y utilizar la historia clínica única y prescripción electrónica, elementos que posibilitan la implantación futura de programas similares. Los nuevos registros y actuaciones asistenciales permitirán una evaluación fiable de su efectividad en relación a la adherencia terapéutica, recaídas y hospitalizaciones

In the healthcare area of Santiago de Compostela (Spain), the therapeutic subgroup "other antipsychotics" represented the fifth largest outpatient expenditure in 2013. More than half of this expenditure corresponded to long-acting parenteral forms of paliperidone and risperidone. Over a 12-month period, the implementation of a pharmaceutical care program based on process management and coordination of actions between health professionals in both levels of care represented savings of € 636,391.01 for the organization and a direct saving of € 16,767.36 and 9,008 trips to the pharmacy for patients. This study shows the efficiency of the program, which was facilitated by its situation in an area of integrated management and the use the unified medical records and electronic prescription, elements that will enable the future implementation of similar programmes. The new registries and healthcare interventions will allow reliable evaluation of their effectiveness in terms of treatment adherence, relapses and hospitalizations

[Efficiency of a pharmaceutical care program for long-acting parenteral antipsychotics in the health area of Santiago de Compostela]. / Eficiencia del programa de seguimiento farmacoterapéutico de antipsicóticos parenterales de acción prolongada en el área sanitaria de Santiago de Compostela.

In the healthcare area of Santiago de Compostela (Spain), the therapeutic subgroup "other antipsychotics" represented the fifth largest outpatient expenditure in 2013. More than half of this expenditure corresponded to long-acting parenteral forms of paliperidone and risperidone. Over a 12-month period, the implementation of a pharmaceutical care program based on process management and coordination of actions between health professionals in both levels of care represented savings of € 636,391.01 for the organization and a direct saving of € 16,767.36 and 9,008 trips to the pharmacy for patients. This study shows the efficiency of the program, which was facilitated by its situation in an area of integrated management and the use the unified medical records and electronic prescription, elements that will enable the future implementation of similar programmes. The new registries and healthcare interventions will allow reliable evaluation of their effectiveness in terms of treatment adherence, relapses and hospitalisations.

Resultados de una metodología para la identificación de distribución inversa de medicamentos en oficinas de farmacia / Methodology for identification of inverse drug distribution, Spain

FUNDAMENTOS: El fenómeno del tráfico inverso en la cadena legal de suministro de medicamentos es una práctica ilícita con graves riesgos para la Salud Pública. El objetivo de este trabajo fue identificar de forma proactiva, oficinas de farmacia que realizan estas conductas ilegales. MÉTODOS: Se cruzaron los datos de facturación al SAS de 52 millones de envases de medicamentos con los de las 496 farmacias de la provincia en un periodo de 29 meses (abril de 2012 a agosto de 2014). Junto con la aplicación del indicador específico definido denominado "porcentaje de sobrecompra", permitió identificar los establecimientos farmacéuticos con alto riesgo de estar implicados en el comercio ilícito. RESULTADOS: Se comprobó que hubo desvío en dos oficinas de farmacia, una rural (de 5.130 envases de medicamentos y beneficio ilícito obtenido de 9.591,78 €) y otra urbana (9.982 envases y 26.885,11 €), los cuales habían pasado desapercibidos en anteriores actuaciones inspectoras. CONCLUSIONES: La metodología implantada permite definir un perfil de oficina de farmacia infractora de alto riesgo en estas prácticas ilícitas, identificarlas, ponderar los fármacos destinados a este comercio ilegal y determinar nuevos medicamentos objeto de desvío. Ayuda a ajustar de forma precisa el cálculo del beneficio ilícito obtenido

BACKGROUND: The phenomenon of reverse drug trafficking in the legal supply chain is an unlawful practice to serious risks to public health. The aims was to identify proactively pharmacies that carry out these illegal activities. METHODS: An analysis was performed through the crossing billing data to SAS of 52 million packs of medicines for the 496 pharmacies in the province over a period of 29 months with the drug packaging data supplied by the distribution entities of the provincewith the implementation of specific indicator defined called 'percentage overbought' allows us to detect those pharmacies at high risk of being involved in this illicit trade. RESULTS: It was tested in two pharmacies one rural and other urban a detour of 5.130 medicine containers and an illicit profit obtained from € 9,591.78 for the first and 9.982 packaging and € 26,885.11 for the second; they had gone unnoticed in previous inspections. CONCLUSIONS: The methodology implemented to define a profile of infringing pharmacies high risk in these illicit practices, identify new ones that had not been sanctioned, weigh the drugs for illegal trade and to identify new drugs subject to diversion; also added as a challenge, it helps to adjust accurately and effectively calculate the illicit profit obtained

[The Reverse Traffic of Drugs Phenomenon: experience in Galicia, Spain]. / El tráfico inverso de medicamentos: experiencia en Galicia.

IInter-state movement of drugs between EU countries by pharmaceutical companies and distribution warehouses is a permitted activity called parallel trade. As Spain is among the states with lower price of these products, its main activity is shipping to other countries; however, a phenomenon has emerged in acquiring drugs for this purpose, called "reverse traffic" that develops without observing the health regulations in the legal distribution channel in our country; in which, the pharmaceutical distribution warehouses, rather than getting drugs from other pharmaceutical companies or pharmaceutical distribution warehouses under the current legislation, obtain them from community pharmacies, thus reversing the legal supply circuit, as this drugs do not end dispensed to the public. This paper studies the risks to public health caused by these practices, detailing the results of health inspections in Galicia, where in relation to the total pharmaceutical establishments sanctioning procedures in the period 2011-2014, were sanctioned for this reason 15 community pharmacies and 5 distribution warehouses, the maximum fines belonging to a network consisting of a pharmaceutical distribution warehouse, with a 1,000,000 € fine and closure for 3 years, and 4 community pharmacies, with 2,400,000 € total fine; It also specifies the methodology of action, identifies the scene of illegal acquisition to make this trade with the greatest economic benefits, highlights the strengths of the success and further action to improve its approach.

El tráfico inverso de medicamentos. Experiencia en Galicia / The reverse traffic of drugs phenomenon. Experience in Galicia, Spain

La circulación intracomunitaria de medicamentos entre países de la Unión Europea realizada por laboratorios farmacéuticos y almacenes mayoristas es una actividad permitida denominada comercio paralelo. Como España se encuentra entre los Estados con menor precio de estos productos, su actividad principal es el envío a otros países. Sin embargo, en la adquisición de fármacos con este objeto ha emergido un fenómeno denominado 'tráfico inverso de medicamentos', que se desarrolla sin observar la normativa sanitaria en el canal legal de distribución en nuestro país. Consiste en que los almacenes mayoristas obtienen los medicamentos de las oficinas de farmacia, en lugar de obtenerlos de otros almacenes o de laboratorios farmacéuticos conforme a la legislación vigente, invirtiendo de esta forma el circuito legal de suministro, ya que las oficinas de farmacia no los dispensan al público. Este trabajo profundiza en los riesgos que para la salud pública ocasionan estas prácticas, detalla los resultados de la inspección de servicios sanitarios en Galicia que, en relación al total de procedimientos sancionadores a establecimientos farmacéuticos del período 2011-2014, fueron saniconados por esta causa 15 oficinas de farmacia y 5 almacenes, correspondiendo las máximas multas a la red formada por un almacén farmacéutico (1.000.000 Euros y cierre por 3 años) y 4 oficinas de farmacia (2.400.000 Euros). Así mismo, se especifica la metodología de actuación y se identifica el escenario de adquisición ilegal para realizar este comercio exterior con mayores beneficios económicos, y se destacan los puntos fuertes de éxito y nuevas acciones para mejorar su abordaje (AU)

Interstate movement of drugs between EU countries by pharmaceutical companies and distribution warehouses is a permitted activity called parallel trade. As Spain is among the states with lower price of these products, its main activity is shipping to other countries ; however, a phenomenon has emerged in acquiring drugs for this purpose, called 'reverse traffic' that develops without observing the health regulations in the legal distribution channel in our country; in which, the pharmaceutical distribution warehouses, rather than getting drugs from other pharmaceutical companies or pharmaceutical distribution warehouses under the current legislation, obtain them from community pharmacies, thus reversing the legal supply circuit, as this drugs do not end dispensed to the public. This paper studies the risks to public health caused by these practices, detailing the results of health inspections in Galicia, where in relation to the total pharmaceutical establishments sanctioning procedures in the period 2011-2014, were sanctioned for this reason 15 community pharmacies and 5 distribution warehouses, the maximum fines belonging to a network consisting of a pharmaceutical distribution warehouse, with a 1,000,000 Euros fine and closure for 3 years, and 4 community pharmacies, with 2,400,000 Euros total fine; It also specifies the methodology of action, identifies the scene of illegal acquisition to make this trade with the greatest economic benefits, highlights the strengths of the success and further action to improve its approach (AU)

Control de la dispensación de medicamentos esteroides anabolizantes androgénicos / Control measures for anabolic androgenic steroid medicines

Los esteroides anabolizantes androgénicos (EAA) pueden producir efectos adversos muy graves cuando se usan sin fin terapéutico. Este trabajo pretende mostrar que los EAA son sustancias susceptibles de desvío ilícito en el canal legal de comercialización, que a su vez, debido a ciertas limitaciones evidenciadas a la hora de perseguir estas actuaciones ilegales por parte de la Inspección de Servicios Sanitarios de la Consellería de Sanidade de la Xunta de Galicia, llevó a una iniciativa normativa para exigir actuaciones adicionales a la farmacia comunitaria en su dispensación. En cuatro inspecciones a oficinas de farmacia se detectó el desvío de un total de 3118 envases de EAA, lo que dio lugar a la apertura de cuatro procedimientos sancionadores, y en dos de ellas se dio traslado a las fuerzas policiales especializadas al haber indicios suficientes de posible desvío a gimnasios, lo cual originó una operación policial (Operación Fitness) (AU)

Anabolic androgenic steroids (AAS) can cause serious adverse effects when used without a therapeutic purpose. This article aims to show that the AAS are susceptible to being sold on the black market. We also aim to describe how certain limitations on the health inspection services of the Galician health service to pursue these illegal actions prompted a regulatory initiative demanding that additional actions be granted to community pharmacies when dispensing AAS. Four pharmacy inspections detected the diversion of a total of 3118 packages of AAS, which led to the opening of four disciplinary proceedings. In two of these, specialized police forces were called in as there was sufficient evidence of possible diversion to gymnasiums, resulting in a police operation called Operation Fitness (AU)

[Control measures for anabolic androgenic steroid medicines]. / Control de la dispensación de medicamentos esteroides anabolizantes androgénicos.

Anabolic androgenic steroids (AAS) can cause serious adverse effects when used without a therapeutic purpose. This article aims to show that the AAS are susceptible to being sold on the black market. We also aim to describe how certain limitations on the health inspection services of the Galician health service to pursue these illegal actions prompted a regulatory initiative demanding that additional actions be granted to community pharmacies when dispensing AAS. Four pharmacy inspections detected the diversion of a total of 3118 packages of AAS, which led to the opening of four disciplinary proceedings. In two of these, specialized police forces were called in as there was sufficient evidence of possible diversion to gymnasiums, resulting in a police operation called Operation Fitness.

Tráfico inverso: una actividad ilícita emergente en la cadena de suministro de medicamentos en España / No disponible

Objetivos: La inversión de los circuitos de comercialización de medicamentos en la red de distribución es una actividad ilícita emergente en España y compromete seriamente la salud pública. Los almacenes farmacéuticos pasan a abastecerse de medicamentos a través de oficinas de farmacias, en lugar deponerlos a su disposición, y las oficinas de farmacia pasan a hacer actividades de suministro a éstos en lugar de dispensarlos a los pacientes. Se ha extendido en el territorio nacional debido a la diferencia de precios entre España y el resto de países de la Unión Europea. El objetivo fue explicar la operativa de estos agentes y dar a conocer una metodología de trabajo inspector efectiva. Material y Métodos: Probar la inversión del canal de suministro de medicamentos entre los agentes: estudio de datos de compras frente a ventas, de entregas y trazabilidad de los pedidos, y de los sistemas de información de facturación al Servicio de Salud. No necesita la colaboración del establecimiento inspeccionado. Resultados: Cuando no se tenía un tipo de infracción administrativa específica ni se conocía la operativa de estas organizaciones: sanciones entre 3.000-78.000 euros como faltas graves. Con un tipo de infracción específico recogido como falta muy grave en la normativa, y una metodología de investigación implementada: sanciones entre 600.000-1.000.000 euros. Conclusiones: La inspección farmacéutica es el principal actor en la lucha contra esta actividad ilícita. Exige un esfuerzo de colaboración interadministrativa. La vía penal, con el apoyo del Grupo de Investigaciones de la Seguridad Social, es una alternativa en determinados casos

Aim: The inversion of medicinal products marketing and distribution network circuits is an emergent illegal activity that results in serious threat to public health. Wholesale distributors obtain medicinal products from high street pharmacies instead of supplying them; and pharmacies become involved in wholesale distribution instead of focusing strictly on their legitimate function of dispensing the medicines to individual patients. This practice has expanded in the country due to price differentials between Spain and other European states. This activity is known as "reverse pharmaceutical traffic". The aims were to explain the operation of the agents involved and provide an effective inspection methodology. Materials and Methods: Based on proving the inversion of the supply channel among the agents involved, hindered by a systematic and deliberate impediment to the inspection tasks. Such methodology includes activities like studies of purchasing data against sales, deliveries against sales, and analysis of the billing information systems to the Health Service not needing the cooperation of the inspected institution. Results: with no specific type of administrative infringement defined and no knowledge of the illicit operations of these organizations: sanctions between 3,000 and 78,000 Euros defined as serious offenses. With a specific type of infringement defined as very serious offenses and a research methodology implemented: sanctions between 600,000 and 1,000,000 Euros. Conclusion: Pharmaceutical inspection is the main actor in the fight against this illegal activity. It requires a major effort in inter-administrative collaboration. The penal system with support of the special police "Grupo de Investigaciones de la Seguridad Social" is alternative in some cases

La gestión electrónica de los procesos de Incapacidad Temporal de corta duración por la inspección de servicios sanitarios en la Comunidad Autónoma de Galicia / No disponible

La Consellería de Sanidade de la Xunta de Galicia ha puesto en marcha un programa electrónico específico para la gestión y el control de los procesos de incapacidad temporal de corta duración. Esta plataforma electrónica de trabajo no sólo consigue una interrelación inmediata entre el Médico de Atención Primaria con el Inspector de Servicios Sanitarios, sino que es una potente herramienta para ambos agentes en el control y gestión de estos procesos. Esta aplicación, llamada Xesit, consigue una gestión mucho más eficiente y efectiva de esta prestación

The "Consellería de Sanidade de la Xunta de Galicia" (Galician regional health department) has developed and implemented a specific computer program in order to manage and control short term incapacity certificates/benefits. This platform allows instant and direct interaction between GPs and "Inspección de Servicios Sanitarios" (Health Services Inspectorate), and it is an important tool to control and manage these processes. This software application, "Xesit", offers a much more effective and efficient way to manage this service