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Biomedical subjects

Emilio J Sanz

Publications and source records attributed to Emilio J Sanz.

8 recordsLinked to original sources

The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task Force.

The European Clozapine Task Force is a group of psychiatrists and pharmacologists practicing in 18 countries under European Medicines Agency (EMA) regulation, who are deeply concerned about the underuse of clozapine in European countries. Although clozapine is the most effective antipsychotic for people with treatment-resistant schizophrenia, a large proportion of them do not have access to this treatment. Concerns about clozapine-induced agranulocytosis and stringent blood monitoring rules are major barriers to clozapine prescribing and use. There is a growing body of evidence that the incidence of clozapine-induced agranulocytosis is very low after the first year of treatment. Maintaining lifelong monthly blood monitoring after this period contributes to unjustified discontinuation of clozapine. We leverage recent and replicated evidence on the long-term safety of clozapine to call for the revision and updating of the EMA's blood monitoring rules, thus aiming to overcome this major barrier to clozapine prescribing and use. We believe the time has come for relaxing the rules without increasing the risks for people using clozapine in Europe.

Clozapine↗

Prescribers' indications for drugs in childhood: a survey of five European countries (Spain, France, Bulgaria, Slovakia and Russia).

BACKGROUND: Indication-based, in comparison to diagnoses-based, drug utilization studies in children are scarce in the literature. AIM: To determine the adequacy of the prescriber's indications for specific drug treatments compared to the current literature in five different European countries; and to show the possibilities of performing indication-based drug utilization studies. DESIGN: a descriptive, cross-sectional, international study. PATIENTS AND METHODS: Randomly selected sample of 12,264 paediatric outpatients seen in consultation rooms attended by paediatricians or general practitioners. Data on patient demographics, diagnoses, and pharmacological treatment, with therapeutic indications for each drug, were collected in pre-designed forms. Diagnoses and indications were coded using the ICD-9 and drugs according to the ATC classifications. RESULTS: Indications were registered for every drug prescribed in all locations. Antibiotic indications considered incorrect (common cold, upper respiratory tract infections, viral infections, general symptoms or "not specified") accounted from 24.1% of the total antibiotics prescribed in Tenerife to 67.4% in Slovakia. Incorrect indication of first-choice antibiotics prescribed in acute otitis media and tonsillitis ranged from 28.9% of total antibiotics use in Russia to 75.4% in Tenerife. Correct antibiotic indications ranged from 23.4% of total antibiotics used in Slovakia to 65.7% in Tenerife. Aspirin use in febrile viral conditions was detected mainly in Toulouse and Russia. CONCLUSION: The main areas for improvement detected were high use of mucolytics, prescription of aspirin in potential or established viral infections, overuse of antibiotics and identification of specific patterns of incorrect antibiotic prescription and clinical entities associated with each location.

Adult↗

Pharmacoepidemiology and the "impact factor".

The field of "Pharmacoepidemiology/Drug Utilization" research has been analysed by studying published research articles under the medical subject headings (MeSH terms) "Pharmacoepidemiology", "Drug Utilization" and "Drug Utilization Review". There were 1822 articles published, and stored in Medline, during the 32-month period between 1 January 2001 and 31 August 2003; these papers might represent a field of research, due to the similarity of MeSH terms used for coding and the set of journals in which the articles were published. A total of 457 articles, representing 25% of all articles in the field, were published in 14 different journals, and 50% of all articles (948) were collected in only 64 different journals. The two main journals publishing research in "Pharmacoepidemiology/Drug Utilization" are Pharmacoepidemiol Drug Saf and the Eur J Clin Pharmacol. These two publications are the official journals of the three main societies in the field and are at least partially focused on this subject, with 45.7% of all articles in Pharmacoepidemiol Drug Saf and 11.1% of all articles in Eur J Clin Pharmacol included under the studied MeSH terms; other journals only occasionally publish papers in this line of research. These two journals are the leaders in pharmacoepidemiology and drug utilization research, having impact factors (IFs) in 2002/2003 above (1.955/1.972 for EJCP) and a bit below (1.092/1.257 for PDS) the middle of the ranking of publications, according to the IF, in the "Pharmacology and Pharmacy" list of the Science Citation Index (SCI).

Bibliometrics↗

Polypharmacy in psychiatric practice in the Canary Islands.

BACKGROUND: Polypharmacy with psychoactive drugs is an increasingly common and debatable contemporary practice in clinical psychiatry based more upon experience than evidence. The objective of this study was to evaluate the prevalence and conditioners of polypharmacy in psychiatric patients. METHOD: A cross-sectional survey was carried out using the Canary Islands Health Service Clinical Records Database. A representative sample (n = 2,647) of patients with mental disorders receiving psychotropic medication was studied. RESULTS: The mean number of psychoactive drugs prescribed was 1.63 +/- 0.93 (range 1-7). The rate of polypharmacy was 41.9%, with 27.8% of patients receiving two drugs, 9.1% receiving three, 3.2% receiving four, and 1.8% of the patients receiving five or more psychotropic drugs. Multiple regression analysis shows that variables sex and diagnosis have a predictive value with regard to the number of psychotropic drug used, being men and schizophrenic patients the most predisposed. Benzodiazepines were the more prevalent drugs in monotherapy, while anticonvulsants and antipsychotics were the more used in combination with other treatment. A questionable very high degree of same-class polypharmacy was evidenced, while multi-class, adjunctive and augmentation polypharmacy seem to be more appropriate. CONCLUSIONS: Almost half of the psychiatric patients are treated with several psychotropics. Polypharmacy is common and seems to be problematic, especially when same class of drugs are prescribed together. Some diagnoses, such as schizophrenia, are associated with an increase risk of Polypharmacy but there is a lack of evidence based indicators that allows for quality evaluation on this practice.

Adolescent↗

Variations in antidepressant prescribing practice: clinical need or market influences?

OBJECTIVE: To assess the antidepressant prescribing patterns of community psychiatrists, and the prescriptions issued by general practitioners and private physicians during 1999 in order to analyse and discuss the intensity and sources of variations between doctors. METHODS: All reimbursed prescriptions for antidepressants written in 1999 by community psychiatrists and general practitioners working for the Canary Islands Health Service at Santa Cruz de Tenerife were collected from official sources. Prescriptions were available individualized for each psychiatrist but were collected globally for the others. Drugs were classified according to the Anatomic Therapeutic Chemical (ATC-1999 edition) System and use was quantified in terms of defined daily doses (DDDs). As an indicator of the quality of drug prescribing, the DU90% was used. RESULTS: The total use of antidepressant in Tenerife was 21.4 DDD/1000 inhabitants/day. The most frequently prescribed substances were fluoxetine, paroxetine and sertraline, which accounted for 58% of all prescriptions. Each psychiatrist used between 10 and 20 different substances and between 15 and 26 different trade names. Prescribing by general practitioners mirrored that of psychiatrist, and private doctors (mainly psychiatrist) were found to have a different pattern of prescribing with higher use of new and uncommon antidepressants. Psychiatrists acknowledge the pressures of promotion by the pharmaceutical industry and half of them recognize a personal relationship with some 'company representatives'. CONCLUSION: There is a remarkable degree of variation in antidepressant prescribing by psychiatrists and general practitioners, this is due to economic and social factors as much as to morbidity differences.

Antidepressive Agents↗

Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis.

BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) have been associated with withdrawal symptoms. We investigated whether use of these drugs in pregnant women might cause neonatal withdrawal syndrome. METHODS: An association between paroxetine and neonatal convulsions was identified in December, 2001, by the data mining method routinely used to screen the WHO database of adverse drug reactions. An information component (IC) measure was used to screen for unexpected adverse reactions relative to the information in the database. We then assessed cases of neonatal convulsions and neonatal withdrawal syndrome associated with drugs included in the anatomical therapeutic chemical groups N06AB and N06AX. FINDINGS: By November, 2003, a total of 93 suspected cases of SSRI-induced neonatal withdrawal syndrome had been reported, and were regarded as enough information to confirm a possible causal relation. 64 of the cases were associated with paroxetine, 14 with fluoxetine, nine with sertraline, and seven with citalopram. The IC-2 SD for the group became greater than 0 in the first quarter of 1991, and the IC increased to 2.68 (IC-2 SD 0.32) by the second quarter of 2003. For each individual compound, the IC-2 SD was greater than 0. INTERPRETATION: SSRIs, especially paroxetine, should be cautiously managed in the treatment of pregnant women with a psychiatric disorder.

Antidepressive Agents, Second-Generation↗