Dolors Capellà

Dispensing is one of the elements of rational drug use. Itis sometimes assumed that this apparently simple pro-cess of supplying medicines to a patient on the basis of a written order can be carried out successfully by anyone who is able to read, count, and pour. However, medical supplies differ from other consumables because the patient usually does not know how to correctly use the medicine, nor is aware of potential adverse effects or interactions with other drugs. As a consequence, it is generally advised that the dispenser has additional knowledge, skills, and ca-pacity to ensure the dispensing process is successful.1 Education is particularly important in self-medication; when patients choose self-care, there is often no possibility to obtain advice from a physician, and so the responsibility of providing appropriate information falls on primary healthcare pharmacists.2 It is within this framework that the concept of the “Seven-Star Pharmacist ” has been pro-posed as a health ...

The aim of this study was to assess effectiveness and safety of antithrombotics for stroke prevention in non-valvular atrial fibrillation in real-use conditions. We used a population-based retrospective cohort study. Information emerges from SIDIAP, a database containing anonymized information from electronic health records from 274 primary healthcare centres of the Catalan Health Institute, Catalonia (Spain), with a reference population of 5 835 000 people. Population includes all adults with a new diagnosis of non-valvular atrial fibrillation registered in SIDIAP from 2007 to 2012. The main outcome of antithrombotics' effectiveness was stroke. The main outcomes of safety were cerebral and gastrointestinal haemorrhages. We also estimated all-cause mortality. We used multivariable Cox proportional hazard models to examine association between antithrombotic treatment and main outcomes. We included 22 205 subjects with non-valvular atrial fibrillation; 40.8% initiated on vitamin K...

The purpose of this study is to describe the pharmacologic management of rate and rhythm and assess which factors are associated with the prescription of these drugs in patients with nonvalvular atrial fibrillation (AF) from the Effectiveness, Safety, and Costs in Atrial Fibrillation study. This retrospective, cross-sectional study describes the pharmacologic rate and rhythm control management strategies adopted during 2012 in all patients diagnosed as having nonvalvular AF in 2007 to 2011. The data source is the Information System for the Improvement of Research in Primary Care database, which is based on primary care electronic health records. To answer the study objectives, 3 multivariate regression models to assess the independent factors associated with the prescription of these drugs were conducted for 2012. The rate and rhythm control drugs assessed were β-blockers, nondihydropyridine calcium channel blockers, antiarrhythmic agents, and digoxin. A total of 21,304 patients were diagnosed as having nonvalvular AF; 11,638 (54.6%) had at least one heart rate measure during 2012. Of them, 7777 (66.8%) received one or more rate and/or rhythm control drugs during 2012. Most patients (5751 [73.9%] of 7777) received only one drug for rate and/or rhythm control. Rate control agents were the most frequently used in 2012, with β-blockers the most prescribed group (4091 patients [52.6%]). A variety of different variables were associated with the prescription of rate and/or rhythm control drugs in the multivariate regression models. The most used pharmacologic treatment of rate and rhythm control in our AF population is β-blockers, indicating that a rate control strategy is preferred in our setting, as widely recommended.

In recent years, new atypical antipsychotic drugs have been marketed. This study aims to analyze the evolution of the consumption pattern and pharmaceutical cost of the antipsychotic drugs during the last years and the impact that the new atypical antipsychotic drugs have had. Based on the ECOM database of the Ministry of Health and Consumer Affairs of Spain, the sales data of the antipsychotic drugs in Catalonia during the 1990-2001 period have been chosen. The drugs have been classified into typical or classical and atypical. Consumption data have been expressed in daily defined dose (DDD) per 1,000 inhabitants and per day of treatment (DID), and cost data in constant euros. Antipsychotic consumption increased from 3.31 DID in 1990 to 6.04 DID in 2001. Typical drugs consumption decreased (from 100 % consumption in 1990 to 46 % in 2001) and that of the atypical ones increased (from 1% consumption in the year 1993 to 54% in the year 2001). A change in the use pattern of different dr...

Sensitivity analyses and publication bias. We provide the results of the two sensitivity analyses: by excluding studies with high risk of bias (Table S20) and by including the results of Nakamura et al. 2014 pooled analysis (Table S21); and the funnel plots of study outcomes (Figure S10). (DOCX 291 kb)

The objective of this paper was to analyze the concept and evolution of translational research in order to explore if it can be used in fields other than health sciences such as higher education. A mini review was conducted using Medline as a main source for identifying papers. We selected papers that appeared to be relevant according to our objective. Data extraction of these papers was made by summarizing documents using short textual descriptions. Search results yielded 1186 papers, 28 of which were finally selected for the mini review. The main aim of translational research is bridging the “know – do” gap. Several multiphase models have been identified. The first described model had two phases (T1, T2) but there are models with three (T1-T3) or four phases (T1T4). However, regardless of the model used, three main gaps exist that can be placed in the knowledge chain underpinning translational research. Translational research could be seen as a bidirectional bridge connecting the ...

To describe the prevalence and concordance of anticholinergic exposure according to 9 published scales, to quantify the relative weight of the drug subtypes included in each scale, and to identify clinical variables related to anticholinergic exposure. Observational and cross-sectional study using 5323 cases of dementia diagnosed in the 7 hospitals of the public health care system of the Health Region of Girona (Spain) between 2007 and 2014 and registered by the Registry of Dementias of Girona (ReDeGi). We used the Pharmacy database that includes all the drugs prescribed by specialist and primary care physicians and dispensed in pharmacies. We calculated the anticholinergic exposure using the scoring rules of each scale. Age, gender, place of residence, dementia subtype, Clinical Dementia Rating score, Mini-Mental Status Examination score, and Blessed Dementia Rating Score at the moment of dementia diagnose were retrieved from the ReDeGi. Prevalence of the annual anticholinergic exp...

We investigated the effect of cholinesterase inhibitors on all-cause discontinuation, efficacy and safety, and the effects of study design-, intervention-, and patient-related covariates on the risk-benefit of cholinesterase inhibitors for Alzheimer's disease. A systematic review and meta-analysis of randomized placebo-controlled clinical trials comparing cholinesterase inhibitors and placebo was performed. The effect of covariates on study outcomes was analysed by means of meta-regression using a Bayesian framework. Forty-three randomized placebo-controlled clinical trials involving 16106 patients were included. All-cause discontinuation was higher with cholinesterase inhibitors (OR = 1.66), as was discontinuation due to adverse events (OR=1.75). Cholinesterase inhibitors improved cognitive function (standardized mean difference = 0.38), global symptomatology (standardized mean difference=0.28) and functional capacity (standardized mean difference=0.16) but not neuropsychiatric...

Cocaine dependence is a severe disorder for which no medication has been approved. Like opioids for heroin dependence, replacement therapy with psychostimulants could be an effective therapy for treatment. To assess the effects of psychostimulants for cocaine abuse and dependence. Specific outcomes include sustained cocaine abstinence and retention in treatment. We also studied the influence of type of drug and comorbid disorders on psychostimulant efficacy. This is an update of the review previously published in 2010. For this updated review, we searched the Cochrane Drugs and Alcohol Group Trials Register, CENTRAL, MEDLINE, Embase and PsycINFO up to 15 February 2016. We handsearched references of obtained articles and consulted experts in the field. We included randomised parallel group controlled clinical trials comparing the efficacy of a psychostimulant drug versus placebo. We used standard methodological procedures expected by Cochrane. We included 26 studies involving 2366 participants. The included studies assessed nine drugs: bupropion, dexamphetamine, lisdexamfetamine, methylphenidate, modafinil, mazindol, methamphetamine, mixed amphetamine salts and selegiline. We did not consider any study to be at low risk of bias for all domains included in the Cochrane 'Risk of bias' tool. Attrition bias was the most frequently suspected potential source of bias of the included studies. We found very low quality evidence that psychostimulants improved sustained cocaine abstinence (risk ratio (RR) 1.36, 95% confidence interval (CI) 1.05 to 1.77, P = 0.02), but they did not reduce cocaine use (standardised mean difference (SMD) 0.16, 95% CI -0.02 to 0.33) among participants who continued to use it. Furthermore, we found moderate quality evidence that psychostimulants did not improve retention in treatment (RR 1.00, 95% CI 0.93 to 1.06). The proportion of adverse event-induced dropouts and cardiovascular adverse event-induced dropouts was similar for psychostimulants and placebo (RD 0.00, 95% CI -0.01 to 0.01; RD 0.00, 95% CI -0.02 to 0.01, respectively). When we included the type of drug as a moderating variable, the proportion of patients achieving sustained cocaine abstinence was higher with bupropion and dexamphetamine than with placebo. Psychostimulants also appeared to increase the proportion of patients achieving sustained cocaine and heroin abstinence amongst methadone-maintained, dual heroin-cocaine addicts. Retention to treatment was low, though, so our results may be compromised by attrition bias. We found no evidence of publication bias. This review found mixed results. Psychostimulants improved cocaine abstinence compared to placebo in some analyses but did not improve treatment retention. Since treatment dropout was high, we cannot rule out the possibility that these results were influenced by attrition bias. Existing evidence does not clearly demonstrate the efficacy of any pharmacological treatment for cocaine dependence, but substitution treatment with psychostimulants appears promising and deserves further investigation.

Atrial fibrillation is the most common arrhythmia. Its management aims to reduce symptoms and to prevent complications through rate and rhythm control, management of concomitant cardiac diseases and prevention of related complications, mainly stroke. The main objective of Effectiveness, Safety and Costs in Atrial Fibrillation (ESC-FA) study is to analyse the drugs used for the management of the disease in real-use conditions, particularly the antithrombotic agents for stroke prevention. The aim of this work is to present the study protocol of phase I of the ESC-FA study and the baseline characteristics of newly diagnosed patients with atrial fibrillation in Catalonia, Spain. The data source is System for the Improvement of Research in Primary Care (SIDIAP) database. The population included are all patients with non-valvular atrial fibrillation diagnosis registered in the electronic health records during 2007-2012. A total of 22 585 patients with non-valvular atrial fibrillation were...

The objective of this paper was to analyze the concept and evolution of translational research in order to explore if it can be used in fields other than health sciences such as higher education. A mini review was conducted using Medline as a main source for identifying papers. We selected papers that appeared to be relevant according to our objective. Data extraction of these papers was made by summarizing documents using short textual descriptions. Search results yielded 1186 papers, 28 of which were finally selected for the mini review. The main aim of translational research is bridging the “know – do” gap. Several multiphase models have been identified. The first described model had two phases (T1, T2) but there are models with three (T1-T3) or four phases (T1- T4). However, regardless of the model used, three main gaps exist that can be placed in the knowledge chain underpinning translational research. Translational research could be seen as a bidirectional bridge connecting th...

To analyze the time trends in anti-osteoporosis medications consumption in Spain between 2000 and 2008 and the influence on such consumption induced by the Information Sheets related to the safety of menopausal hormone therapy and strontium ranelate published by the Spanish Agency of Medicines and Health Products (AEMPS). Purchase data of anti-osteoporosis medications from 2000 to 2008 were obtained from the Spanish Ministry of Health. This information includes the pharmacy sales data of medicinal products reimbursed by the Spanish National Health Service. Anti-osteoporosis medications consumption data were expressed as defined daily dose per 1 000 inhabitants per day in women aged 50 or more. During the study period, anti-osteoporosis medications consumption showed a continuous increase. The greatest increase was observed with bisphosphonates, particularly alendronate and risedronate in their weekly formulations. Strontium ranelate consumption was low but continuously increased and new information concerning its safety in 2007 had no effect on its consumption. The use of menopausal hormone therapy remained stable until 2003, and from then presented a continuous decrease until 2008. Raloxifene utilization increased from 2000 to 2004 and decreased thereafter. Calcitonin utilization decreased uninterruptedly and teriparatide was infrequently used. This study reports a marked change in osteoporosis treatment in Spain, which includes an important increase in anti-osteoporosis medication use, particularly of bisphosphonates and a decrease in menopausal hormone therapy use secondary to the new information about their safety.

Pyrithyldione, a sedative-hypnotic drug with a poor clinical pharmacological development, was associated with anecdotal cases of agranulocytosis in the 1940s in the USA, in the 1960s and 1970s in the ex-Democratic Republic of Germany and in the 1980s in Japan. We describe the estimation of the risk of agranulocytosis associated with its use in Spain, which led to its withdrawal from the market. In collaboration with the haematology units of all the hospitals in a defined area (3.3-3.9 x 10(6) inhabitants), all cases of agranulocytosis meeting strict diagnostic criteria were identified. Each case - defined as an episode of agranulocytosis - was reviewed by a haematologist without knowledge of previous drug exposures. Cases and age-, gender- and hospital-matched controls were interviewed with a structured questionnaire about previous drug exposures. In addition, in order to estimate the risk of pyrithyldione-associated agranulocytosis through a case-population approach, its consumption among the cases was compared with its consumption among the general population. After a follow-up of 66.5 x 10(6) person-years, 330 cases of agranulocytosis (230 community cases) were assembled. Reliable information on previous exposures was obtained for 204 cases. They were compared with 1314 controls. Eleven patients (14 cases, 6.9%) and zero controls had been exposed to pyrithyldione. The adjusted OR was 200.11 (CI 95% 22. 62-infinity). All patients were female; none had a fatal outcome; three exhibited positive rechallenge; and all had concomitantly taken other drugs. Although pyrithyldione was a prescription-only medicine, only 8% had been dispensed with medical prescriptions. Assuming the worst case, i.e. that all the exposed cases could be attributed to pyrithyldione, the incidence was 35.6 cases per 100, 000 patient-years (95% CI, 18.9-60.9), which gives a risk ratio estimate of 109.6 (57.5-191.5) if compared with the incidence of agranulocytosis among the non-exposed population [3.26 cases (CI 95% 2.83-3.71) per 10(6) inhabitants and per year]. Pyrithyldione was viewed by pharmacists as a mild hypnotic, and apparently this had conferred to this drug an unjustified image of safety. The National Commission of Pharmacovigilance recommended to the Ministry of Health its withdrawal from the market when eight cases of agranulocytosis had been identified. However, it took more than 2 years to withdraw it, and six additional cases occurred in the study area. This illustrates the need for quick regulatory action when pharmacoepidemiological data suggest an unfavourable benefit/risk ratio.

Psychostimulant dependence is characterized by dopamine deficit, which could be reversed with indirect dopamine agonists (IDAs). A systematic review and meta-analysis of randomized, parallel-group, placebo-controlled clinical trials assessing the efficacy of ...

We present the experience of the introduction of the subject of bioethics in a medical school in order to give to the 73 students of 5th degree skills to handle ethical conflicts in their practice. The main teaching method used was problem-based learning (PBL). Skills objectives are described. The course was structured with a theoretical seminar (2 hours of duration), a workshop (2 hours of duration), 4 cases of PBL (24 hours of duration in total) and a role playing workshop (2 hours of duration). The seminar was aimed at the acquisition of theoretical knowledge. The PBL cases provided critical appraisal, obtaining knowledge, and application. The Role Playing set out for the practical demonstration of skills acquired in a simulated environment. A continuous assessment of students was performed throughout their practice on the PBL cases (40% of the final score) and also a final evaluation of the course was carried out via exam (60% of the final score). Students completed a course and...