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Biomedical subjects

F Haramburu

Publications and source records attributed to F Haramburu.

At least 55 records · Page 3Linked to original sources

[The French system of evaluation of dependence: establishment in a legal system].

The French system of evaluation of dependence has been defined in the French Public Health Code by decree 99-249 of 31 March 1999. It was created by health authorities 10 years earlier and concerns dependence and abuse, which were previously just submitted to control under the designation of non-conforming use and misuse. The consultative function of the narcotics and psychotropics commission has been reinforced and its mission extended to include evaluation. Cooperation with different actors has been organized. This is based on the complexity of the methods of evaluation and the impact of decisions concerning control and/or information. The same principles organize the cooperation of this system at the European and international levels.

France↗

[Inter-regional differences in dysthyroidism due to amiodarone: comparison of spontaneous notifications in Aquitaine, Midi-Pyrenees and Languedoc-Roussillon].

Amiodarone hydrochloride is used in the treatment of ventricular and supraventricular arrhythmias. Because of its iodinated structure, thyroid dysfunction can occur during amiodarone therapy. The reported overall incidence is variable (2-24 per cent) and depends on several factors (past thyroid history, daily iodine intake,...). The present retrospective (1990-97) study was performed using the French pharmacovigilance database in order to compare the frequency of hypo- and hyperthyroidism in three areas in the South of France: Midi-Pyrénées, Aquitaine and Languedoc-Roussillon. For each case, the following data were recorded: age, sex, dysthyroidism history, dosage, duration and indication of amiodarone and delay to onset of dysthyroidism. We collected respectively 37, 50 and 9 cases of hypothyroidism in Midi-Pyrénées, Aquitaine and Languedoc-Roussillon and 20, 69 and 11 cases of hyperthyroidism respectively in the same areas. These data show the predominance of reported amiodarone-induced hyperthyroidism in Aquitaine and Languedoc-Roussillon. Hypothyroidism seems more frequent in Midi-Pyrénées, a non-maritime area. The sex ratio (male/female) was significantly different for the occurrence of hypothyroidism in Midi-Pyrénées (1.8 versus 0.5 in Aquitaine and 0.8 in Languedoc-Roussillon). The delay to onset of hypothyroidism was significantly shorter in Midi-Pyrénées (17.1 months +/- 24.5) when compared with Aquitaine (28.7 +/- 28.1) or Languedoc-Roussillon (43.4 +/- 45). Our results show an interregional difference in the occurrence of hypo/hyperthyroidism due to amiodarone.

Adverse Drug Reaction Reporting Systems↗

[Benzodiazepine consumption: survey of community pharmacies in Aquitaine].

For many years, the use of benzodiazepines has been particularly high in France. This use can be described through pharmacy delivery. A cross-sectional one-day survey was conducted in June 1999, within a randomly selected network of community pharmacies in Aquitaine. Pharmacists were asked to interview each patient presenting with a prescription form including at least one benzodiazepine. A total of 58 pharmacies participated in this study; 328 patients were included representing 356 benzodiazepines prescribed. Among the 20 different benzodiazepines concerned, bromazepam, lorazepam and alprazolam represented more than half (54 per cent) of the prescriptions. The mean age of the patients was 62 years (median: 64) and 70 per cent of them were women. Most patients (93 per cent) were known to the pharmacist and 86 per cent had benzodiazepines prescribed by a single physician. In most cases (77 per cent), the prescribed benzodiazepine had been used for more than one year and in one quarter for more than five years. For 81 per cent of chronic users, no dose increase was observed. This study confirmed that long-term use of benzodiazepines is frequent, particularly in the elderly. This use is commonly accepted by health professionals as well as by patients, although it clearly reflects the dependence potential of benzodiazepines.

Adult↗

Effectiveness and safety profile of leflunomide in rheumatoid arthritis: actual practice compared with clinical trials.

OBJECTIVE: Leflunomide, an immunosuppressant agent for treating rheumatoid arthritis, was first marketed in France in 2000. Three years after its launch, we sought to assess its prescription patterns in the real world of prescription and use, and to see if its efficacy and safety profiles observed during clinical trials were confirmed. METHODS: All patients treated with leflunomide from May 2000 to April 2003 in the Department of Rheumatology of the Bordeaux University Hospital were identified, and their treatment patterns and outcome ascertained. This was compared to data from clinical trials. RESULTS: 116 were included (mean age = 55 years, 70% women). Almost 21.7% stopped treatment for lack of efficacy (after a mean delay of 3.6 months), 16% for secondary loss of efficacy (median = 7 months), and 32% for the occurrence of an adverse event (half within 4 months). Over a similar time frame in clinical trials, in patients of about the same age and sex but with less severe disease, the corresponding figures were 7-17% for lack or loss of efficacy, and 14-22% for adverse effects. At one year of follow-up, the discontinuation rate was 70% in the cohort compared to 28-47% in clinical trials. DISCUSSION: The differences between the two populations confirm the need to conduct post-marketing studies in order to obtain better knowledge on the effectiveness and safety of a new drug. In many cases, a simple drug utilization study can provide relevant information on the degree of shift between populations included in clinical trials and those treated in real life.

Antirheumatic Agents↗

[Computerized data processing in the Pharmacovigilance Center of Bordeaux-Aquitaine. Analysis of clientele of the Center].

Practitioners inquiries addressed to our Drug Information Centre are computerized since 1986. Their analysis allows to pinpoint special problems and needs for practitioners information, and to detect new adverse drug reactions. Time series analysis of calls (according to the practitioners specialities or geographic stay) allows to evaluate the effectiveness of the services provided by the Bordeaux Drug Information Centre.

Drug Information Services↗