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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., (Copyright © 2021 The Authors. Publicado por Elsevier España, S.L.U. All rights reserved.)

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., (Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.)

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., (Copyright © 2013 Elsevier España, S.L.U. All rights reserved.)

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., (Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.)

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., (2009 Elsevier España, S.L. All rights reserved.)

Objective: To analyze whether for an equal health problem there are gender differences in the drugs used in an adult population attended in the Health Care Centers of the Valencian Community (Spain)., Methods: A cross-sectional analytical study was carried out between February-August 1997. The independent variables were: socio-economic parameters, frequency of visits, and self-perceived or diagnosed health problems, and the dependent one the number of drugs consumed., Results: Of the 812 patients considered, 801 consumed medication. Eighty percent of the health problems for which drugs were used involved 5 apparatuses and systems (mean: 3.3 health problems/patient). The 5 most consumed therapeutic groups accounted for 81% of the total (mean: 4.5 drugs/patient). Significant differences were recorded, with greater female consumption in the central nervous system and genitourinary tract therapeutic groups, and with greater male consumption in relation to the respiratory system and systemic anti-infectious therapy. Drug use increased with age, lowest educational level, lowest professional categories, and with the highest frequency of visits to the physician. Significant differences were also recorded in drug use by occupational status, marital status and family structure. The multivariate analysis showed the number of health problems and the frequency of visits accounted for 82.2% of the variability of the variable <>. The variability accounted for by gender was explained by the variable health problems, the main factor underlying drug consumption among women and men., Conclusion: The main finding is probably that women do not use larger numbers of drugs than men if health problems and frequency of visits are controlled.

Objective: To assess the quality and relevance of adverse drug reactions (ADRs) published as Letters to the Editor (LE) in Spanish medical journals., Design: Observational study., Participants: LE on adverse drug reactions published over 5 years (1994-98)., Setting: Four Spanish medical journals (Medicina Clínica, Revista Clínica Española, Atención Primaria and Anales de Medicina Interna)., Main Measurements: Patient characteristics, drugs, ADR, causality algorithm, minimum criteria, and publication relevance., Results: Out of 2244 LE, 204 (9.1%) reported ADRs, which included 235 cases. The therapeutic subgroups most commonly implicated were anticoagulants and antiplatelet drugs, antibiotics, and antineoplastic agents; 20.4% of the drugs were recently marketed. ADRs most commonly involved the nervous system (13.6%), liver (10.2%), skin and appendages (9.8%), general reactions (9.8%), and the digestive system (8.1%). The reactions were moderate in 50.2% of cases and severe/fatal in 34%. The mean causality algorithm value (5.9+/-2.2) was similar among journals. Of the ADRs, 28 (11.9%) were definitive, 182 (77%) possible or probable, and 26 (11.1%) improbable or conditional; 10.2% were unknown. There were no differences in the mean minimum publication criteria (9.5+/-1.2). Publication relevance was 3.2+/-1.6 points, and higher in Medicina Clínica., Conclusions: ADRs constitute an important part of LE in the journals studied. The causal relationship is acceptable, the documentation quality is high, with few unknown reactions and ADRs to recently marketed drugs. Relevance is generally low, although greater in Medicina Clínica.

Objective: To analyse the relationship between patient's sex and quality of medicine taken by monitoring the most pertinent predictive variables., Design: Observational cross-sectional study., Setting: Thirteen Health Centres in the Community of Valencia., Participants: Adult users, selected by consecutive sampling., Main Measurements: A semi-structured questionnaire collected the following variables: social and personal details, use of medicines for health problems, frequency of use of services, and place where prescription was issued. The quality of the medication was measured by its intrinsic value (IV)., Results: 412 of the 812 patients were women. Men took more medication with a high IV, and women more with an unacceptable IV. Women over 45 took more medication with a not-high IV. Multivariate analysis showed: a) women took one and a half times more medicines with a not-high IV than men, with differences not significant, and b) in the 45-64 age-group, being a woman operated as a modifier of effect, increasing prevalence of consumption of not-high IV to two and a half times more than men. This was adjusted for frequency of attendance, health problems and where the prescription was issued., Conclusions: The study helped clarify the influence of gender on the quality of medicine, by pointing to the greater likelihood of women between 45 and 64 taking lower-quality medication. In addition, it showed the effect of where the prescription was issued and of health problems on explaining this difference in consumption.

Objective: Given the possibility of adverse side-effects, interactions with medicines and poisoning by contaminants among herbal medicine consumers (HM), we aimed to describe the consumption of HM by health centre users being treated with medicines., Design: Cross-sectional, observational study.Setting. Thirteen health centres in the Community of Valencia., Patients and Other Participants: Users of either sex, over 14, chosen for a study of use of medicines to find differences between the sexes., Measurements and Main Results: The study variables, age, gender, education, consumption of medicines and use of HM, were gathered from the clinical records, the long-treatment card and an ad hoc structured survey. 801 out of 812 users took medicines. 159 took HM (19.6%; 95% CI, 16.9-22.3); average age 55.8 (SD, 16.5); women 58.5% (95% CI, 50.8-66.1). They took 226 HM (mean of 1.42; 95% CI, 1.32-1.52). Men consumed more HM (p < 0.05). There were no differences in consumption of HM for age, educational background or number of medicines taken. 42.8% (95% CI, 35.1-50.2) of those who took HM attended for consultation over 10 times in the previous year. 96.9% (95% CI, 93.7-98.4) of HM were taken by self-medication. They were consumed: <> by 36.7% (95% CI, 30.4-43.0); stomach problems, 19.5% (95% CI, 14.3-24.6); nerves/depression, 12.8% (95% CI, 8.5-17.2); intestinal disorders, 10.6% (95% CI, 6.6-14.6); insomnia 5.8% (95% CI, 3.1-9.6). 49.1% (95% CI, 42.6-52.6) were manufactured HM., Conclusions: One of every five patients being treated with medicines is also taking HM by self-medication. The health authorities and doctors should advise of the risks to health and of the counter-indications of these products.