Neuropeptide Y receptor 1 and galanin receptor 2 (NPY1R-GALR2) interactions in the dentate gyrus and their relevance for neurogenesis and cognition.

Introduction: This study may unveil novel insights into the interactions between neuropeptide Y receptor 1 (NPY1R) and galanin receptor 2 (GALR2), in the dentate gyrus of the dorsal hippocampus, shedding light on their role in neurogenesis and cognitive functions. Existing literature highlights the potential of these interactions in enhancing learning and memory, yet detailed mechanisms remain underexplored. Methods: Utilizing intracerebroventricular injections of GALR2 and NPY1R agonists in Sprague-Dawley male rats, we examined neurogenesis via markers PCNA and DCX, and memory consolidation through the object-in-place task over a three-week period. Results: Significant increases in NPY1R-GALR2 co-localization and neuroblast proliferation were observed, alongside enhanced memory consolidation. These findings suggest a synergistic effect of NPY1R and GALR2 activation on cognitive functions. Discussion: Our findings may foster the development of novel heterobivalent or multitargeting drugs, affecting NPY1R-GALR2 interaction, and suggest a future pharmacogical strategy for improving learning and memory found in many brain diseases. Further research is encouraged to explore these mechanisms in pathological models.

Effect of Nordic Sensi® Chair on Behavioral and Psychological Symptoms of Dementia in Nursing Homes Residents: A Randomized Controlled Trial.

BACKGROUND: Behavioral and psychological symptoms of dementia (BPSD) are present in most people with dementia (PwD), including Alzheimer's disease. There is consensus that non-pharmacological therapies represent the first line of treatment to address BPSD. OBJECTIVE: We explore the efficacy of the use of a rocking chair (Nordic Sensi® Chair, NSC) in the treatment of BPSD in nursing home residents with moderate and severe dementia. METHODS: We carried out a 16-week randomized, single-blind, controlled, clinical trial with PwD admitted to nursing homes. Participants were assigned to a treatment group (n = 40) that received three times a week one session per day of 20 minutes in the NSC and a control group (n = 37). The Neuropsychiatric Inventory-Nursing Home (NPI-NH) was used as primary efficacy outcome. Occupational distress for the staff was evaluated using the NPI-NH Occupational Disruptiveness subscale (NPI-NH-OD). Statistical analyses were conducted by means of a Mixed Effects Model Analysis. RESULTS: Treatment with the NSC was associated with a beneficial effect in most of BPSD, as reflected by differences between the treatment and control group on the NPI-NH total score (mean change score -18.87±5.56 versus -1.74±0.67, p = 0.004), agitation (mean change score -2.32±2.02 versus -0.78±1.44, p = 0.003) and irritability (mean change score -3.35±2.93 versus -1.42±1.31, p = 0.004). The NPI-NH-OD total score also improved the most in the treatment group (mean change score -9.67±7.67 versus -7.66±6.08, p = 0.003). CONCLUSIONS: The reduction in overall BPSD along with decreased caregiver occupational disruptiveness represent encouraging findings, adding to the potential of nonpharmacological interventions for nursing home residents living with dementia.

Prevalence and Clinical Conditions Related to Sarcopaenia among Older Persons Living in the Community.

(1) Background: In health care and in society at large, sarcopaenia is a disorder of major importance that can lead to disability and other negative health-related events. Our study aim is to determine the prevalence of sarcopaenia among older people attended in primary care and to analyse the factors associated with this age-related clinical condition; (2) Methods: A multicentre cross-sectional study was conducted of 333 community-dwelling Spanish adults aged 65 years or more. Sociodemographic, clinical, functional, anthropometric, and pharmacological data were collected. Sarcopaenia was defined following European Working Group on Sarcopaenia in Older People (EWGSOP) criteria; (3) Results: Sarcopaenia was present in 20.4% of the study sample, and to a severe degree in 6%. The intensity of the association between sarcopaenia and frailty was weak-moderate (Cramer V = 0.45). According to the multinomial logistic regression model performed, sarcopaenia was positively associated with age and with the presence of psychopathology (OR = 2.72; 95% CI = 1.30-5.70) and was inversely correlated with body mass index (OR = 0.73, 95% CI = 0.67-0.80; (4) Conclusions: Sarcopaenia commonly affects community-dwelling older persons and may be associated with age, body mass index, and psychopathology. The latter factor may be modifiable or treatable and is therefore a possible target for intervention.

Assessing Prevalence and Factors Related to Frailty in Community-Dwelling Older Adults: A Multinomial Logistic Analysis.

Frailty is an age-related clinical condition that typically involves a deterioration in the physiological capacity of various organ systems and heightens the patient's susceptibility to stressors. For this reason, one of the main research goals currently being addressed is that of characterising the impact of frailty in different settings. The main aim of this study is to determine the prevalence of Fried's frailty phenotype among community-dwelling older people and to analyse the factors associated with frailty. In this research study, 582 persons aged 65 years or more participated in this cross-sectional study that was conducted at primary healthcare centres in Málaga, Spain. Sociodemographic, clinical, functional and comprehensive drug therapy data were compiled. The relationship between the independent variables and the different states of frailty was analysed by using a multinomial logistic regression model. Frailty was present in 24.1% of the study sample (95% CI = 20.7-27.6) of whom 54.3% were found to be pre-frail and 21.6% were non-frail. The study variable most strongly associated with frailty was the female gender (OR = 20.54, 95% CI = 9.10-46.3). Other factors found to be associated with the state of frailty included age, dependence for the instrumental activities of daily living (IADL), polymedication, osteoarticular pathology and psychopathology. This study confirms the high prevalence of frailty among community-dwelling older people. Frailty may be associated with many factors. Some of these associated factors may be preventable or modifiable and, thus, provide clinically relevant targets for intervention. This is particularly the case for depressive symptoms, the clinical control of osteoarthritis and the use of polypharmacy.

Level of Palliative Care Complexity in Advanced Cancer Patients: A Multinomial Logistic Analysis.

The current treatment approach for patients in palliative care (PC) requires a health model based on shared and individualised care, according to the degree of complexity encountered. The aims of this study were to describe the levels of complexity that may be present, to determine their most prevalent elements and to identify factors that may be related to palliative complexity in advanced-stage cancer patients. An observational retrospective study was performed of patients attended to at the Cudeca Hospice. Socio-demographic and clinical data were compiled, together with information on the patients' functional and performance status (according to the Palliative Performance Scale (PPS)). The level of complexity was determined by the Diagnostic Instrument of Complexity in Palliative Care (IDC-Pal©) and classified as highly complex, complex or non-complex. The impact of the independent variables on PC complexity was assessed by multinomial logistic regression analysis. Of the 501 patients studied, 44.8% presented a situation classed as highly complex and another 44% were considered complex. The highly complex items most frequently observed were the absence or insufficiency of family support and/or caregivers (24.3%) and the presence of difficult-to-control symptoms (17.3%). The complex item most frequently observed was an abrupt change in the level of functional autonomy (47.6%). The main factor related to the presence of high vs. non-complexity was that of performance status (odds ratio (OR) = 10.68, 95% confidence interval (CI) = 2.81-40.52, for PPS values < 40%). However, age was inversely related to high complexity. This study confirms the high level of complexity present in patients referred to a PC centre. Determining the factors related to this complexity could help physicians identify situations calling for timely referral for specialised PC, such as a low PPS score.

Factors Associated with Health-Related Quality of Life in Community-Dwelling Older Adults: A Multinomial Logistic Analysis.

The main aim of this study was to determine the association of various clinical, functional and pharmacological factors with the physical (PCS) and mental (MCS) summary components of the health-related quality of life (HRQoL) of community-dwelling older adults. Design: Cross-sectional study. Patients and setting: Sample of 573 persons aged over 65 years, recruited at 12 primary healthcare centres in Málaga, Spain. Sociodemographic, clinical, functional, and comprehensive drug therapy data were collected. The main outcome was HRQoL assessed on the basis of the SF-12 questionnaire. A multinomial logistic regression model was constructed to study the relationship between independent variables and the HRQoL variable, divided into intervals. The average self-perceived HRQoL score was 43.2 (± 11.02) for the PCS and 48.5 (± 11.04) for the MCS. The factors associated with a poorer PCS were dependence for the instrumental activities of daily living (IADL), higher body mass index (BMI), number of medications, and presence of osteoarticular pathology. Female gender and the presence of a psychopathological disorder were associated with worse scores for the MCS. The condition that was most strongly associated with a poorer HRQoL (in both components, PCS and MCS) was that of frailty (odds ratio (OR) = 37.42, 95% confidence interval (CI) = 8.96-156.22, and OR = 20.95, 95% CI = 7.55-58.17, respectively). It is important to identify the determinant factors of a diminished HRQoL, especially if they are preventable or modifiable.

Polifarmacia: algo más que números / Polypharmacy: Something more than just numbers

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2015 Beers Criteria and STOPP v2 for detecting potentially inappropriate medication in community-dwelling older people: prevalence, profile, and risk factors.

PURPOSE: To comparatively assess the prevalence rates of potentially inappropriate medications (PIMs) obtained by the former and latest versions of American Geriatrics Society Beers Criteria (AGS BC) and screening tool of older person's potentially inappropriate prescriptions (STOPP), and analyze the factors of influence on PIM. METHODS: Cross-sectional study including 582 community-dwelling older adults over the age of 65. Sociodemographic, clinical, functional, and comprehensive drug therapy data were collected. The primary endpoint was the percentage of patients receiving at least one PIM. RESULTS: A total of 3626 prescriptions were analyzed. PIMs were detected in 35.4% and 47.9% of patients according to the STOPP v1 and the 2012 AGS BC, respectively. This percentage rose to 54% when 2015 AGS BC were used and reached 66.8% with STOPP v2. The kappa coefficient between STOPP v2 and its former version was lower than the one between the updated Beers Criteria and their former version (0.41 vs 0.85). The agreement was good (0.65) between both latest criteria. The number of medications, psychological disorders, and insomnia were predictors of PIM. A novel finding was that bone and joint disorders increased the odds for PIM by 78%. CONCLUSIONS: The 2015 AGS BC showed high sensitivity and good applicability to the European older patients. Both updated tools identified some pharmacological groups (benzodiazepines, PPIs, and opioids, among others) and certain health problems (insomnia, psychological disorders, and osteoarticular diseases) as factors of influence on PIM. Based on these findings, interventions aimed at promoting appropriate use of medications should be developed.

Spanish list of potentially inappropriate drugs in the elderly (ES-PIA project).

PURPOSE: In the last decades, different criteria have been developed for detecting inappropriate prescription in older patients. In Spain, translations and adaptations of international lists are available but it would be necessary a national list which could cope with the peculiarities of our health system, existing pharmaceutical market, and prescription habits. We propose in this project the creation of a Spanish potentially inappropriate drugs list which could be applicable in our clinical scenario. METHODS: We use a Delphi method involving 25 experts from different backgrounds (Clinical Pharmacology, Geriatrics, Rational Use of Drugs and Pharmacy, Primary Care and Pharmacoepidemiology, and Pharmacovigilance) that were asked to participate in two-round questionnaires. For analysis, current recommendations of Worth and Pigni were applied, and every statement was classified into one of three groups: strong, moderate, or low agreement. Statements with strong agreement were accepted to be part of the inadequate prescription list. Moderate agreement statements were selected to enter the second questionnaire, and statements with low agreement were further analyzed to determine if it was due to heterogeneity or due to dispersion in the answers. RESULTS: The first questionnaire consisted of 160 proposed sentences, of which 106 reached a high agreement, 32 a moderate agreement, and 22 a low agreement. All sentences proposed in the second questionnaire reached a strong agreement. The total accepted sentences were 138. CONCLUSIONS: We offer a list of inadequate prescription in older patients adapted to the Spanish pharmacopeia and according to the prescription habits in our environment.

Herbal and Dietary Supplement-Induced Liver Injuries in the Spanish DILI Registry.

BACKGROUND & AIMS: There have been increasing reports of liver injury associated with use of herbal and dietary supplements, likely due to easy access to these products and beliefs among consumers that they are safer or more effective than conventional medications. We aimed to evaluate clinical features and outcomes of patients with herbal and dietary supplement-induced liver injuries included in the Spanish DILI Registry. METHODS: We collected and analyzed data on demographic and clinical features, along with biochemical parameters, of 32 patients with herbal and dietary supplement-associated liver injury reported to the Spanish DILI registry from 1994 through 2016. We used analysis of variance to compare these data with those from cases of liver injury induced by conventional drugs or anabolic androgenic steroid-containing products. RESULTS: Herbal and dietary supplements were responsible for 4% (32 cases) of the 856 DILI cases in the registry; 20 cases of DILI (2%) were caused by anabolic androgenic steroids. Patients with herbal and dietary supplement-induced liver injury were a mean age of 48 years and 63% were female; they presented a mean level of alanine aminotransferase 37-fold the upper limit of normal, 28% had hypersensitivity features, and 78% had jaundice. Herbal and dietary supplement-induced liver injury progressed to acute liver failure in 6% of patients, compared with none of the cases of anabolic androgenic steroid-induced injury and 4% of cases of conventional drugs. Liver injury after repeat exposure to the same product that caused the first DILI episode occurred in 9% of patients with herbal and dietary supplement-induced liver injury vs none of the patients with anabolic androgenic steroid-induced injury and 6% of patients with liver injury from conventional drugs. CONCLUSION: In an analysis of cases of herbal and dietary supplement-induced liver injury in Spain, we found cases to be more frequent among young women than older patients or men, and to associate with hepatocellular injury and high levels of transaminases. Herbal and dietary supplement-induced liver injury is more severe than other types of DILI and re-exposure is more likely. Increasing awareness of the hepatoxic effects of herbal and dietary supplements could help physicians make earlier diagnoses and reduce the risk of serious liver damage.

Assessment of off-label prescribing: profile, evidence and evolution / Evaluación de las prescripciones fuera de ficha técnica: perfil, evidencia y evolución

Objective: The objectives of the study were to describe the extent and profile of off-label prescriptions, to evaluate the level of evidence supporting these indications, to assess the research activity in these conditions, and to determine to what extent these were authorized as new indications five years after the application. Methods: A cross-sectional study including all applications conducted in the Hospital Universitario Reina Sofía in Córdoba during 2010. Analysis: level of evidence according to the criteria by SIGN-NICE (Scottish Intercollegiate Guidelines Network, National Institute for Health and Care Excellence) and CEBM (Centre for Evidence-based Medicine), registered clinical trials (source: ClinicalTrials.gov), and review of product specifications and monthly newsletters from the Spanish Agency of Medicines and Medical Devices. Results: There were 190 applications for off-label prescription for 82 different indications. The most requested medications were: tacrolimus, mycophenolate, colistimethate and everolimus; the immunosuppressant group had the highest number of uses for non-approved indications. Out of the applications, 52.4% were based on some clinical trial, while the rest had a low level of evidence (observational studies and case reports). We have found on-going clinical trials for 67% of the indications, but new indications in their product specifications have only been authorized for nine drugs (bevacizumab, deferasirox, everolimus, lenalidomide, methotrexate, sildenafil, sorafenib, raltegravir and tenofovir). Conclusions: We have detected a major volume of off-label prescription without good supporting evidence, which identifies these indications and medications as interesting research lines, but that require follow-up in terms of effectiveness and costs (AU)

Objetivo: Los objetivos del estudio fueron describir la magnitud y el perfil de las prescripciones fuera de ficha técnica (off-label), evaluar el nivel de evidencia en el que se sustentan estas indicaciones, valorar la actividad investigadora en estas enfermedades y determinar en qué grado se autorizan como nuevas indicaciones transcurridos cinco años desde la solicitud. Métodos: Estudio transversal que incluyó todas las solicitudes realizadas en el Hospital Universitario Reina Sofía de Córdoba durante 2010. Análisis: nivel de evidencia según criterios de SIGN-NICE (Scottish Intercollegiate Guidelines Network, National Institute for Health and Care Excellence) y del CEBM (Centre for Evidence-based Medicine), ensayos clínicos registrados (fuente: ClinicalTrials.gov) y la revisión de fichas técnicas e informes mensuales de la Agencia Española del Medicamento. Resultados: Hubo 190 solicitudes offlabel para 82 indicaciones distintas. Los medicamentos más solicitados fueron tacrolimus, micofenolato, colistimetato y everolimus, constituyéndose el grupo de inmunosupresores como el de mayor número de usos en indicaciones no aprobadas. El 52,4% de las solicitudes estaban basadas en algún ensayo clínico, mientras que el resto tuvo un bajo nivel de evidencia (estudios observacionales y casos). Hemos encontrado ensayos clínicos en activo para el 67% de las indicaciones, pero solo nueve fármacos han visto autorizadas nuevas indicaciones en su ficha técnica (bevacizumab, deferasirox, everolimus, lenalidomida, metotrexato, sildenafilo, sorafenib, raltegravir y tenofovir). Conclusiones: Se ha detectado un importante volumen de usos offlabel en ausencia de buena evidencia, lo que identifica a estas indicaciones y medicamentos como líneas de investigación interesantes pero con necesidad de seguimiento de efectividad y costes (AU)

Assessment of off-label prescribing: profile, evidence and evolution.

OBJECTIVES: The objectives of the study were to describe the extent and profile of off-label prescriptions, to evaluate the level of evidence supporting these indications, to assess the research activity in these conditions, and to determine to what extent these were authorized as new indications five years after the application. METHODS: A cross-sectional study including all applications conducted in the Hospital Universitario Reina Sofía in Córdoba during 2010. ANALYSIS:  level of evidence according to the criteria by SIGN-NICE (Scottish Intercollegiate Guidelines Network, National Institute for Health and Care Excellence) and CEBM (Centre for Evidence-based Medicine), registered clinical trials (source: ClinicalTrials.gov), and review of product specifications and monthly newsletters from the Spanish Agency of Medicines and Medical Devices. RESULTS: There were 190 applications for off-label prescription for 82 different indications. The most requested medications were: tacrolimus, mycophenolate, colistimethate and everolimus; the immunosuppressant group had the highest number of uses for non-approved indications. Out of the applications, 52.4% were based on some clinical trial, while the rest had a low level of evidence (observational studies and case reports). We have found on-going clinical trials for 67% of the indications, but new indications in their product specifications have only been authorized for nine drugs (bevacizumab, deferasirox, everolimus, lenalidomide, methotreate, sildenafil, sorafenib, raltegravir and tenofovir). CONCLUSIONS: We have detected a major volume of off-label prescription without good supporting evidence, which identifies these indications and medications as interesting research lines, but that require follow-up in terms of effectiveness and costs.

Objetivo: Los objetivos del estudio fueron describir la magnitud y el perfil de las prescripciones fuera de ficha técnica (off-label), evaluar el nivel de evidencia en el que se sustentan estas indicaciones, valorar la actividad investigadora en estas enfermedades y determinar en qué grado se autorizan como nuevas indicaciones transcurridos cinco años desde la solicitud.Métodos: Estudio transversal que incluyó todas las solicitudes realizadas en el Hospital Universitario Reina Sofía de Córdoba durante 2010. Análisis: nivel de evidencia según criterios de SIGN-NICE (Scottish Intercollegiate Guidelines Network, National Institute for Health and Care Excellence) y del CEBM (Centre for Evidence-based Medicine), ensayos clínicos registrados (fuente: ClinicalTrials.gov) y la revisión de fichas técnicas e informes mensuales de la Agencia Española del Medicamento.Resultados: Hubo 190 solicitudes off-label para 82 indicaciones distintas. Los medicamentos más solicitados fueron tacrolimus, micofenolato, colistimetato y everolimus, constituyéndose el grupo de inmunosupresores como el de mayor número de usos en indicaciones no aprobadas. El 52,4% de las solicitudes estaban basadas en algún ensayo clínico, mientras que el resto tuvo un bajo nivel de evidencia (estudios observacionales y casos). Hemos encontrado ensayos clínicos en activo para el 67% de las indicaciones, pero solo nueve fármacos han visto autorizadas nuevas indicaciones en su ficha técnica (bevacizumab, deferasirox, everolimus, lenalidomida, metotrexato, sildenafilo, sorafenib, raltegravir y tenofovir).Conclusiones: Se ha detectado un importante volumen de usos offlabel en ausencia de buena evidencia, lo que identifica a estas indicaciones y medicamentos como líneas de investigación interesantes pero con necesidad de seguimiento de efectividad y costes.

Assessing Potentially Inappropriate Prescribing in Community-Dwelling Older Patients Using the Updated Version of STOPP-START Criteria: A Comparison of Profiles and Prevalences with Respect to the Original Version.

Emerging and changing evidence made it necessary to update STOPP-START criteria, and version 2 was published recently. In this study the objectives were to determine the prevalence of potentially inappropriate medication prescribing (PIM) in primary care using STOPP versions 1 (v1) and 2 (v2), as well as 2012 AGS Beers criteria, and analyze the factors associated with inappropriate prescribing according to STOPP/START v2. A cross-sectional study was carried out including community-dwelling older adults over the age of 65. Sociodemographic, clinical, functional and comprehensive drug therapy data were collected. The primary endpoint was the percentage of patients receiving at least one PIM. This variable was measured using three tools: STOPP v1, 2012 AGS Beers criteria and STOPP v2. Similarly, the percentage of patients receiving at least one potential prescribing omission (PPO) was calculated using START versions 1 and 2. A total of 1,615 prescriptions were reviewed. The median number of medications per patient was 7.1 drugs (±3.8). The prevalence of elderly people exposed to polypharmacy (≥5 medications) was 72.9%, whereas 28.4% of the participants took ≥10 drugs regularly. PIM were present in 18.7%, 37.3% and 40.4% of participants, according to the STOPP v1, 2012 Beers criteria and STOPP v2, respectively. According to STOPP v2, the number of medications taken (OR: 1.14, 1.06-1.25), the presence of a psychological disorder (OR: 2.22, 1.13-4.37) and insomnia (OR: 3.35, 1.80-6.32) were risk factors for taking a PIM. The prevalence of PPOs was 34.7% and 21.8% according to version 1 and 2, respectively. In conclusion, STOPP-START criteria have been remarkably modified, which is evidenced by the different prevalence rates detected using version 2, as compared to version 1. In fact, the level of agreement between version 1 and the updated version is only moderate. Special attention should be paid on benzodiazepines, which keep being the most frequent PIM.

Estudio de las prescripciones farmacológicas en niños a nivel de atención primaria: evaluación de los usos off-label o fuera de ficha técnica / Drug prescriptions study in the outpatient setting: assessment of off-label uses in children

OBJETIVO: Evaluar el perfil de prescripción y los usos off-label (fuera de ficha técnica [FT]) y unlicensed(medicamentos no autorizados específicamente para niños) de medicamentos a nivel ambulatorio. DISEÑO: Estudio transversal. Emplazamiento: Consultas de pediatría de 2 centros de salud urbanos y sala de urgencia general del Hospital Materno-Infantil de Málaga. PARTICIPANTES: Niños de 0-14 años que acudiesen a consulta y se les prescribiese al menos un medicamento. MEDICIONES PRINCIPALES: Variables sociodemográficas, motivo de consulta y medicación. Clasificación de las prescripciones según información contenida en FT. RESULTADOS: Se incluyeron un total de 388 niños, una submuestra de 105 (27%) atendidos en urgencias, y se valoraron 462 prescripciones, que involucraron 74 principios activos diferentes. Cada niño recibió un promedio de 1,7 fármacos (IC 95%: 1,6-1,9), siendo los más prescritos ibuprofeno, paracetamol, amoxicilina-clavulánico y budesonida. El grupo terapéutico más empleado y con mayor variedad de fármacos fue el respiratorio. El 27,4% de las prescripciones (IC 95%: 23,5-31) fueron off-label, constituyéndose como causa más frecuente el uso del fármaco para una edad distinta de la autorizada (60%; IC 95%: 54,1-63), seguida de distinta dosis (21,5%; IC 95%: 18-25), diferente indicación (12%; IC 95%: 9,2-15) y el 7% por distinta vía de administración (IC 95%: 5,4-10). CONCLUSIONES: La tasa de usos off-label presenta cifras intermedias, pudiendo recibir este tipo de prescripciones una tercera parte de los niños. Esto no significa que sean prescripciones incorrectas, pero es recomendable respaldarlas con la mejor evidencia, así como seguir las directrices de la normativa sobre medicamentos en situaciones especiales

OBJECTIVE: to evaluate the prescription profile and to assess the off-label and unlicensed uses of medicines among non-hospitalised pediatric PATIENTS: DESIGN: cross-sectional study. SETTING: pediatric units in two urban health centers and general emergency room (Hospital Materno-Infantil, Málaga). MAIN MEASUREMENTS: sociodemographics variables, reasons for consultation and information about therapeutic medications. The classification of prescriptions was established according to information requirements contained in the Summary of Products Characteristics (SPC). RESULTS: A total of 388 children were included (a subsample of 105 treated in the emergency room). Four hundred sixty-two prescriptions (involving 74 different active ingredients) were evaluated. Each infant received and average of 1,7 drugs (95% CI: 1,6-1,9). The most prescribed medicines were ibuprofen, paracetamol, amoxicillin-clavulanate and budesonide. The therapeutic group with the greatest variety of drugs was the respiratory group.27,4% (95% CI: 23,5-31) of prescriptions were off-label and the main cause was different age (60%; 95% CI: 54,1-63), followed by different dose (21,5%; 95% CI: 18-25), different indication (12%; 95% CI: 9,2-15) and different route of administration (7%; 95% CI: 5,4-10). CONCLUSIONS: The rate of off-label uses presents intermediate figures. Around one third of the paediatric outpatients in our sample are exposed to at least one off-label or unlicensed prescription. We should, however, point out that such usage is based on scant official, quality information, although it is not necessarily incorrect. Evidence-based medicine should be encouraged to improve drug therapy in children, as well as following the rules on drugs in special situations

Efectos de la edad, el periodo de defunción y la cohorte de nacimiento en la mortalidad por enfermedad isquémica del corazón en el sur de España / Age, period, and cohort effects on mortality from ischemic heart disease in southern Spain

Introducción y objetivos: La cardiopatía isquémica es la primera causa de muerte y una de las cuatro principales causas de carga de enfermedad en el mundo. El objetivo de este trabajo es evaluar los efectos edad-periodo-cohorte la mortalidad por cardiopatía isquémica en Andalucía (sur de España) y en cada una de sus provincias durante el periodo 1981-2008. Métodos: Se realizó un estudio ecológico poblacional. Se analizaron las 145.539 defunciones por cardiopatía isquémica ocurridas en Andalucía durante el periodo de estudio a edades comprendidas entre 30 y 84 años. Se estimó un modelo de regresión no lineal con funciones spline para cada sexo y área geográfica. Resultados: En la tasa de mortalidad masculina y femenina a partir de 30 años de edad se observa tendencia a aumentar. El riesgo de muerte para varones y mujeres fue descendiente para las cohortes nacidas después de 1920 y con una pendiente más pronunciada después de 1960 entre los varones. El análisis del efecto periodo mostró que el riesgo de mortalidad masculina y femenina se mantuvo estable desde 1981 hasta 1990, aumentó entre 1990 y 2000 y volvió a disminuir desde 2000 hasta 2008. Conclusiones: Los efectos edad-periodo-cohorte en la mortalidad fueron similares en todas las provincias de Andalucía y el conjunto de la comunidad autónoma. Si los efectos cohorte y periodo persisten, la mortalidad masculina y femenina por enfermedad isquémica cardiaca continuará disminuyendo (AU)

Introduction and objectives: Ischemic heart disease is the leading cause of death and one of the top 4 causes of burden of disease worldwide. The aim of this study was to evaluate age-period-cohort effects on mortality from ischemic heart disease in Andalusia (southern Spain) and in each of its 8 provinces during the period 1981-2008. Methods: A population-based ecological study was conducted. In all, 145 539 deaths from ischemic heart disease were analyzed for individuals aged between 30 and 84 years who died in Andalusia in the study period. A nonlinear regression model was estimated for each sex and geographical area using spline functions. Results: There was an upward trend in male and female mortality rate by age from the age of 30 years. The risk of death for men and women showed a downward trend for cohorts born after 1920, decreasing after 1960 with a steep slope among men. Analysis of the period effect showed that male and female death risk first remained steady from 1981 to 1990 and then increased between 1990 and 2000, only to decrease again until 2008. Conclusions: There were similar age-period-cohort effects on mortality in all the provinces of Andalusia and for Andalusia as a whole. If the observed cohort and period effects persist, male and female mortality from ischemic heart disease will continue to decline (AU)

[Drug prescriptions study in the outpatient setting: assessment of off-label uses in children]. / Estudio de las prescripciones farmacológicas en niños a nivel de atención primaria: evaluación de los usos off-label o fuera de ficha técnica.

OBJECTIVE: to evaluate the prescription profile and to assess the off-label and unlicensed uses of medicines among non-hospitalised pediatric patients. DESIGN: cross-sectional study. SETTING: pediatric units in two urban health centers and general emergency room (Hospital Materno-Infantil, Málaga). MAIN MEASUREMENTS: sociodemographics variables, reasons for consultation and information about therapeutic medications. The classification of prescriptions was established according to information requirements contained in the Summary of Products Characteristics (SPC). RESULTS: A total of 388 children were included (a subsample of 105 treated in the emergency room). Four hundred sixty-two prescriptions (involving 74 different active ingredients) were evaluated. Each infant received and average of 1,7 drugs (95% CI: 1,6-1,9). The most prescribed medicines were ibuprofen, paracetamol, amoxicillin-clavulanate and budesonide. The therapeutic group with the greatest variety of drugs was the respiratory group. 27,4% (95% CI: 23,5-31) of prescriptions were off-label and the main cause was different age (60%; 95% CI: 54,1-63), followed by different dose (21,5%; 95% CI: 18-25), different indication (12%; 95% CI: 9,2-15) and different route of administration (7%; 95% CI: 5,4-10). CONCLUSIONS: The rate of off-label uses presents intermediate figures. Around one third of the paediatric outpatients in our sample are exposed to at least one off-label or unlicensed prescription. We should, however, point out that such usage is based on scant official, quality information, although it is not necessarily incorrect. Evidence-based medicine should be encouraged to improve drug therapy in children, as well as following the rules on drugs in special situations.

Optimizing elderly pharmacotherapy: polypharmacy vs. undertreatment. Are these two concepts related?

PURPOSE: This study aimed to estimate the prevalence of polypharmacy and potential prescribing omissions (PPO) and their related factors in community-dwelling elderly patients and to examine any possible relationship between these two concepts. METHODS: A cross-sectional study was carried out including patients 65 years of age or over living on the island of Lanzarote (Spain). Sociodemographic, clinical and functional variables were collected, together with full data on drug therapy. The percentage of patients receiving ≥5 medications (polypharmacy) and the percentage of patients receiving at least one PPO according to Screening Tool to Alert doctors to Right Treatment (START) criteria (underprescription) were the two primary endpoints. RESULTS: A total of 1844 medications were prescribed to the 407 patients included in our study. The overall prevalence of polypharmacy was 45 %. The risk factors associated with polypharmacy were comorbidity (OR 1.98, 95 % CI 1.63-2.44), limitations in activities of daily living (ADL; OR 3.0, 95 % CI 1.51-6.11), and being prescribed a drug in the Anatomical Therapeutic Chemical classification (ATC) C group (OR 7.92, 95 % CI 4.10-16.25) or in the N group (OR 3.80, 95 % CI 2.25-6.55). START criteria identified a total of 303 PPO in 170 (41.8 %) subjects. The risk of PPO increased by 60 % for every additional point in the Charlson Comorbidity Index (OR 1.60, 95 % CI 1.35-1.91). Polypharmacy also independently predicted the odds of at least one PPO according to START criteria (OR 2.19, 95 % CI 1.36-3.55). CONCLUSION: Our findings show high rates of polypharmacy and PPO, as well as a clear relationship between these two concepts.

Age, Period, and Cohort Effects on Mortality From Ischemic Heart Disease in Southern Spain.

INTRODUCTION AND OBJECTIVES: Ischemic heart disease is the leading cause of death and one of the top 4 causes of burden of disease worldwide. The aim of this study was to evaluate age-period-cohort effects on mortality from ischemic heart disease in Andalusia (southern Spain) and in each of its 8 provinces during the period 1981-2008. METHODS: A population-based ecological study was conducted. In all, 145 539 deaths from ischemic heart disease were analyzed for individuals aged between 30 and 84 years who died in Andalusia in the study period. A nonlinear regression model was estimated for each sex and geographical area using spline functions. RESULTS: There was an upward trend in male and female mortality rate by age from the age of 30 years. The risk of death for men and women showed a downward trend for cohorts born after 1920, decreasing after 1960 with a steep slope among men. Analysis of the period effect showed that male and female death risk first remained steady from 1981 to 1990 and then increased between 1990 and 2000, only to decrease again until 2008. CONCLUSIONS: There were similar age-period-cohort effects on mortality in all the provinces of Andalusia and for Andalusia as a whole. If the observed cohort and period effects persist, male and female mortality from ischemic heart disease will continue to decline.