Drug Prescription Profiles in Patients with Polypharmacy in Spain: A Large-Scale Pharmacoepidemiologic Study Using Real-World Data.

We aimed to identify and compare medication profiles in populations with polypharmacy between 2005 and 2015. We conducted a cross-sectional study using information from the Computerized Database for Pharmacoepidemiologic Studies in Primary Care (BIFAP, Spain). We estimated the prevalence of therapeutic subgroups in all individuals 15 years of age and older with polypharmacy (≥5 drugs during ≥6 months) using the Anatomical Therapeutic Chemical classification system level 4, by sex and age group, for both calendar years. The most prescribed drugs were proton-pump inhibitors (PPIs), statins, antiplatelet agents, benzodiazepine derivatives, and angiotensin-converting enzyme inhibitors. The greatest increases between 2005 and 2015 were observed in PPIs, statins, other antidepressants, and ß-blockers, while the prevalence of antiepileptics was almost tripled. We observed increases in psychotropic drugs in women and cardiovascular medications in men. By patient´s age groups, there were notable increases in antipsychotics, antidepressants, and antiepileptics (15-44 years); antidepressants, PPIs, and selective ß-blockers (45-64 years); selective ß-blockers, biguanides, PPIs, and statins (65-79 years); and in statins, selective ß-blockers, and PPIs (80 years and older). Our results revealed important increases in the use of specific therapeutic subgroups, like PPIs, statins, and psychotropic drugs, highlighting opportunities to design and implement strategies to analyze such prescriptions' appropriateness.

[Adequacy of the safety of metamizole and agranulocytosis]. / Adecuación de la seguridad del metamizol y agranulocitosis.

OBJECTIVE: To analyze whether the drug safety update issued by the Spanish Agency of Medicines and Healthcare Products (AEMPS), dated October 30, 2018, on agranulocytosis and metamizole contains accurate and necessary information to protect patients from the presentation of this adverse reaction (AR) and if the official documentation of medicines containing metamizole for doctors, pharmacists and the general population conforms to the guidelines of the AEMPS to reduce this risk. SETTING AND PARTICIPANTS: Drug safety update, bibliographic search, information at the European Medicines Agency on metamizole drugs marketed in Spain, technical datasheets, leaflets, Bot PLUS Health Information Database and Catalog of Pharmaceutical Specialties. Notification of 4cases of agranulocytosis due to metamizole after the drug safety update was issued. MAIN INTERVENTIONS AND MEASUREMENTS: Comparison of the key points of the drug safety update and official documents on metamizole with the bibliography. Description of the 4cases of agranulocytosis due to metamizole and application of the causality and severity algorithm. RESULTS: The drug safety update contains omissions and contradiction in respect to the bibliography and the actual use of metamizole in healthcare practice. The official documents show a lack of updating, unapproved indications and doses higher than those recommended. The drug safety update has not stopped the presentation of cases of agranulocytosis due to metamizole. CONCLUSIONS: The AEMPS drug safety update can be improved and it is necessary to update the official information documents on metamizole for health professionals and patients in order to decrease the risk of agranulocytosis.

Evolution of polypharmacy in a spanish population (2005-2015): A database study.

PURPOSE: To analyze the evolution of the prevalence of polypharmacy and excessive polypharmacy in a Spanish population, and to improve the identification of patients with polypharmacy. METHODS: A descriptive, annual cross-sectional observational study was carried out. PATIENTS: individuals over 14 years of age included in a multiregional primary care database of the Spanish population (BIFAP). ANALYSIS: prescription data. Period 2005-2015. VARIABLES: proportion of patients with polypharmacy (simultaneous prescription of ≥5 drugs) and excessive polypharmacy (≥10 drugs) for at least 6 months, according to sex and age groups. A trend analysis of the studied period was performed (overall, and by sex and age groups). RESULTS: The data are reported on a comparative basis (2005 vs 2015). Number of patients analyzed: 2664743 vs 4 002 877. The prevalence of polypharmacy increased significantly (2.5% vs 8.9%, P-value for trend <0.001), being greater in females throughout the study period and in the group aged ≥80 years (P-value for trends <0.001). The prevalence of excessive polypharmacy also increased significantly (0.1% vs 1%, P-value for trend <0.001), being higher in the group aged ≥80 years (P-value for trend <0.001). The proportion of patients with no chronic treatment decreased (80.2% vs 63.1%). CONCLUSIONS: The prevalence of polypharmacy in this Spanish population has tripled in the period 2005-2015, while excessive polypharmacy has increased 10-fold. These increments are seen in both sexes and in all age groups, particularly in individuals over 80 years of age. The proportion of patients without chronic treatments has decreased.

Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: study protocol for a randomised non-inferiority trial.

BACKGROUND: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TAU) in a primary health care setting. METHODS: A two-arm randomised controlled non-inferiority trial will be carried out, with repeated measures (baseline, 3 months, 6 months, and 12 months) under two conditions: b-CBT and TAU. The b-CBT program will consist in three face-to-face sessions and eight online sessions. The TAU is defined as the routine care delivered by the general practitioner for the treatment of depression in primary care. The primary outcome is a symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Other secondary outcomes will be considered (e.g., quality of life, treatment preference). All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. 156 participants will be recruited (78 per arm). DISCUSSION: It is expected that b-CBT is clinically non-inferior when compared to TAU. This is the first study in Spain to use a b-CBT format in primary and specialized care, and this format could be an efficacious and cost-effective therapeutic strategy for the treatment of depression. TRIAL REGISTRATION: ClinicalTrials.gov NCT02361684. Registered on 8 January 2015. Currently recruiting participants.

Community outbreak of cutaneous leishmaniasis in La Ribera region of Valencia, Spain: Public Health measures. / Brote comunitario de leishmaniasis cutánea en la comarca de La Ribera: a propósito de las medidas de Salud Pública.

INTRODUCTION: Outbreaks of human leishmaniasis are not very common in Spain, despite being considered an endemic disease. In this study, a new outbreak in the Valencian Community is presented. Its principal objective is to describe the clinical-epidemiological characteristics and to present the main Public Health measures established to contain the outbreak. METHODS: A case was defined as anyone residing in the village of Tous (in Valencian Community), diagnosed with leishmaniasis according to clinical and laboratory criteria, defined by the Epidemiological Surveillance Network, and date of symptoms onset between 1 January 2012 and 31 December 2013. A descriptive analysis was performed on the epidemiological variables collected. RESULTS: A total of 19 cases were reported from the 28th week of 2012 to the 30th week of 2013. Adults were most affected by the disease (73%). The most common clinical form was cutaneous leishmaniasis (89%). More than three-quarters (79%) of cases were confirmed by PCR. Species typing was performed on seven samples, with the parasite Leishmania infantum being identified. Patient outcome was favourable after physical (31%), or pharmacological (69%) treatment. Some kind of residual damage was observed in 37% of cases. Different measures were applied, aimed at health professionals, and vector and reservoir control, as well as general recommendations to the population for the containment of the outbreak. CONCLUSIONS: This cutaneous leishmaniasis outbreak confirms the endemic nature and the high prevalence of the disease in the Mediterranean area. The most commonly used treatment was intralesional meglumine antimoniate. A comprehensive plan of action had to be developed in order to control the outbreak.

[An experience of collaboration between primary health care and mental health care in La Ribera Department of Health (Valencia, Spain)]. / Experiencia de colaboración entre atención primaria y salud mental en el Departamento de Salud La Ribera, 7 años después.

Despite the high prevalence of mental health problems among patients attending primary care, diagnosis and treatment of these disorders remain inadequate. Sound training of primary care physicians in how to manage mental health problems is needed to reduce the health, economic and social impact associated with these disorders. Among other elements, there is a need for cooperation between primary care physicians and mental health services. Distinct models are available for such collaboration. In 2006, our health department started a collaboration between these two levels of heath care, using a liaison model. Delays until the first specialist visit were reduced and satisfaction among health professionals increased, although these results should be interpreted with caution. Evidence has recently accumulated on the usefulness of the collaborative model, but evaluation of this model and extrapolation of its results are complex. We intend to evaluate our model more thoroughly, similar to other projects in our environment.

[Evolution of the use of antidepressants, anxiolytics and hypnotics in Valencia. Period 2000-2010]. / Evolución de la utilización de antidepresivos, ansiolíticos e hipnóticos en la Comunitat Valenciana. Período 2000-2010.

OBJECTIVE: To describe the evolution in the use of antidepressants (AD), anxiolytics (A) and hypnotics (H) in the Comunitat Valenciana (CV) between 2000 and 2010, their expenditure, and the cost of the defined daily dose (DDD). DESIGN: Retrospective observational study. SETTING: Prescriptions covered by the health public service of the CV during the period 2000-2010. MEASUREMENTS: Consumption of the therapeutic groups N06A (antidepressants), N05B (anxiolytics) and N05C (hypnotics) from the pharmacy database of the public Valencian Health Agency measured in defined daily dose per 1.000 inhabitants. RESULTS: During the period of study the use of AD increased by 81.2% and A and H, 11.7%. Selective serotonin reuptake inhibitors were the most prescribed AD and Selective serotonin and norepinephrine reuptake inhibitors experienced the higher rise (386.8%). The increase of escitalopram was 1.013%. Lorazepam, alprazolam and diazepam, accounted for the 80.4% of the anxyolitics, and lormetazepam and zolpidem the 88.7% of the hypnotics. The expenditure rise of AD was by 78.2% and that of the A and H was 14.5%; the cost of the DDD of both decreased by 29%. CONCLUSIONS: Antidepressant utilization has experienced a remarkable rise between 2000 and 2010 while that of A and H has been mild even though they are still more consumed than AD. In spite of the reduction of the DDD cost in both therapeutic groups, the whole expenditure on AD in the CV is still growing.

[Variability in the measurement of the pharmaceutical prescription quality by autonomous communities]. / Variabilidad en la medición de la calidad de prescripción por comunidades autónomas.

AIM: To examine how the different Spanish health regions are evaluating pharmaceutical prescription quality and the type of prescribing indicators used. DESIGN: Cross-sectional study. SETTING: The 17 Spanish Autonomous Communities during the period from January to December 2007. MEASUREMENTS: Definition and type of prescribing indicators, measurement units. RESULTS: We obtained information from 16 of the 17 CCAA through their health services. All health services had developed quality indicators of drug prescription. The number of indicators varied from 3 to 22 between regions. Most of the regions are using indicators based on adequate selection of drugs. Nine of the 16 CCAA are also including prevalence indicators and only the Basque Country and Cantabria are using indicators based on the quality of the therapeutic process. Nine CCAA use the number of packs as measurement unit and the other seven CCAA measure prescriptions in defined daily doses (ddd). The indicators most frequently used are: percentage of new drugs in 15 CCAA (93%), omeprazole in total IBP drugs in 13 (81.2%), percentage of generic drugs in 11 (68.7%) and selection of NSAID in 10 (62%). CONCLUSION: Each regional health service has developed its own set of drug prescription quality indicators. Consequently, there is great variability between regions in the assessment of the quality of drug prescription. Common indicators are needed in order to establish a benchmarking process between regional health services.