Alfonso Velasco

Trends in the consumption of opioid analgesics in Spain. Higher increases as fentanyl replaces morphine

ObjectiveDuring the past few years there have been changes in the availability of opioids in Spain, and new policies on palliative care have been implemented. The aim of this study was to describe the new pattern of opioid consumption in Spain and the associated economic impact.MethodsA search in the ECOM (Especialidades Consumo de Medicamentos) database of the Ministry of Health and Consumer Affairs for the 1992–2006 period was carried out. This database contains information on prescriptions of primary care medicines that are covered by the National Health System in Spain.ResultsSince 1992, overall opioid consumption has increased 14-fold, from 0.3 DDD/1000 inhabitants per day to 4.4 DDD/1000 inhabitants per day. For the six drugs that require a special prescription form – morphine, methadone, oxycodone pethidine, tilidine and fentanyl – consumption increased from 0.1 DDD/1000 inhabitants per day in 1992 to 1.2 in 2006. During this same period, the total costs of these prescriptions increased by 36.8-fold, and the cost per day and per patient doubled.ConclusionA huge increase in opioid consumption has occurred during the time period covered by this study, with fentanyl consumption accounting for most of that increase. Although oral morphine is the first-choice drug among strong opioids, fentanyl is currently the most consumed.

Antidepressant-induced hepatotoxicity.

Depression is a chronic, severe and increasingly prevalent illness associated with substantial morbidity, mortality and healthcare costs. Antidepressant drugs, the cornerstone of depression treatment, are not devoid of adverse effects, including hepatotoxicity. To review the risk of liver toxicity related to major antidepressants, the authors have followed structural criteria focusing on the underlying mechanism presumably involved and the role of particular chemical structures. The clinicopathological expression goes from transient increases in liver enzymes to fulminant liver failure. Classical antidepressants such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (TCAs) seem to have the highest potential to induce liver damage compared with the newer drugs such as selective serotonin re-uptake inhibitors (SSRIs). The potential for severe hepatotoxicity associated with nefazodone is stressed. Guidelines for therapy and prevention of antidepressant-induced hepatotoxicity are also discussed.

Trends in the consumption of attention deficit hyperactivity disorder medications in Castilla y León (Spain): changes in the consumption pattern following the introduction of extended release methylphenidate

Attention deficit hyperactivity disorder (ADHD) is the most diagnosed behavioural disorder in children and adolescents; prevalence has been estimated around 5%. Studies have shown an increase in the use of ADHD medications during the last years. The aim of the present study was to learn the pattern and the evolution of ADHD medication consumption in Castilla y León (Spain).

HMG CoA Reductase Inhibitors and Impotence Two Case Series from the Spanish and French Drug Monitoring Systems

AbstractObjective: HMG CoA Reductase inhibitors, more commonly called statins, are used in the pharmacological management of hyperlipidaemia. At present, the use of these drugs is increasing worldwide. They have been linked to certain adverse drug reactions, including impotence. The aim of the present study is to explore the basis of the association between statin use and impotence using data from spontaneous reports. Method: We analysed the cases of impotence associated with statins that were collected by the Spanish and French pharmacovigilance systems. We used cases of impotence as a numerator and consumption data as a denominator to estimate the cumulative reported incidence of impotence. Results: Thirty-eight cases of impotence associated with statins have been identified in the database of the Spanish pharmacovigilance system; overall, there was a temporal sequence of events in all cases and the adverse reaction disappeared after drug withdrawal in 93% of the cases. Sixteen patients had also been treated with other drugs. In France, 37 cases were collected. In 85% of these cases recovery from the adverse reaction was observed after drug withdrawal; there was a positive rechallenge in five cases, and 15 patients were receiving other drugs at the same time. No significant differences among reported incidences with different statins were found. Conclusion: Considering the widespread use of this drug class and the under-reporting of this particular reaction it could affect a large number of patients. The reaction seems to be reversible in most of the cases after drug withdrawal. Doctors should be aware of this potential adverse reaction when prescribing statins to their patients.

Effects of fluoxetine hydrochloride and fluvoxamine maleate on different preparations of isolated guinea pig and rat organ tissues

1. Fluoxetine and fluvoxamine reinforced the response to norepinephrine of isolated rat vas deferens incubated in Krebs-Henseleit solution. 2. This reinforcement disappeared when cocaine, 17 beta-estradiol, and propranolol were added to the incubation medium. 3. Fluoxetine and fluvoxamine did not have antimuscarinic effect, but they did have antihistaminic effect, and at high concentrations they inhibited the contraction induced by potassium ion on the isolated rat uterus preparation (IC50 3.99 x 10(-6) and 1.82 x 10(-5) M, respectively).

Trends in the consumption of antidepressants in Castilla y León (Spain). Association between suicide rates and antidepressant drug consumption

To learn the evolution of antidepressant and lithium use in Castilla y León (Central Spain) and its relationship with suicide rates.

Gynaecomastia Associated with Proton Pump Inhibitors A Case Series from the Spanish Pharmacovigilance System

AbstractObjective: Proton pump inhibitors (PPIs) are widely used in the management of peptic ulcer and related symptoms. They have been linked to certain endocrine adverse reactions, including gynaecomastia. The aim of the present study is to investigate the association between the use of PPIs and the development of gynaecomastia. Methods: Reports of cases of gynaecomastia that had putatively been induced by PPIs and that had been collected by the Spanish Pharmacovigilance System via the ‘yellow card’ scheme, were analysed. Reporting odds ratios (RORs) were calculated as a measure of disproportionality. Results: Twenty-four cases of gynaecomastia associated with PPIs were identified in the database of the Spanish Pharmacovigilance System. Overall, there was a clear temporal sequence of events in all cases and the adverse effect disappeared after drug withdrawal in most of the cases; 14 patients were also receiving other drugs at the time of the adverse effect. The ROR for omeprazole exposure versus no exposure, but not that for other PPIs, showed a statistically significant elevation (ROR adjusted for age 5.23; 95% CI 3.32, 8.26). Conclusion: Considering the widespread use of PPIs, gynaecomastia may affect a large number of patients. In most cases, the condition seems to be reversible with drug withdrawal. Doctors should be aware of this potential adverse reaction when prescribing PPIs to their patients over long periods of time.

Impact of Selective Financing of Drugs on Pharmaceutical Expenditure Control in the Province of Valladolid, Spain

SummaryIn July 1993, public financing for 1692 drug specialities was stopped in Spain (a drug speciality is a medicine with a defined composition, particular pharmaceutical form and dosage, prepared for immediate use, ready and packaged for dispatching to the public, with uniform name, packaging and labelling which has been granted authorisation by the State Administration and registered in the Pharmaceutical Specialities Register). We designed a study to assess the repercussions of this so-called ‘selective financing’ on expenditure contral. The aims of the study were 2-fold: first, to forecast the consumption of drug specialities that are reimbursable on the Spanish National Health Service, had selective financing not been applied; and, secondly, to estimate the impact of selective financing on drug consumption.For short- and medium-term forecast estimates, time-series analysis was used, and was applied to monthly consumption data. The measures of consumption used were the number of prescriptions per 1000 patients, and cost [in Spanish pesetas (Pta;

Heart Rhythm Disturbances Associated With Rupatadine: A Case Series From the Spanish and Portuguese Pharmacovigilance Systems

US1 = Pta123.9, February 1996)] per 1000 patients. Data were analysed from January 1986 up to the introduction of selective financing.We found that drug specialities excluded by selective financing showed, overall, a negative increase (i.e. the consumption of drugs that were excluded under selective financing decreased). The repercussion forecast, both in terms of prescription numbers and cost, of the 13 excluded drug specialities that had the highest pre-selective financing consumption is decreasing compared with total consumption. The assessment of the repercussions of selective financing up to December 1994 was made by calculating the difference between actual expenditures and forecast expenditures in the absence of selective financing. This repercussion, in prescriptions, was lower than the percentage of the 1692 excluded drug specialities relating to total consumption in 1992. The repercussion in cost, nevertheless, was greater than expected during the first year of selective financing application. This could be attributable to average price containment of drug specialities due to causes other than selective financing itself. The economic impact of selective financing after 1 year of application was reduced because of accommodation phenomena.

Comparative study of the effects of clozapine and clothiapine in different preparations of guinea pig and rat isolated organs.

We searched the Spanish and Portuguese pharmacovigilance databases for spontaneous case reports of heart rhythm disturbances associated with rupatadine and other new H1 antihistamines. Five cases were found involving patients treated with rupatadine (13.9% of all reports relating to this drug). In all five cases, the reaction started after exposure and resolved when the drug was discontinued. In two cases, rupatadine was the only medication being taken by the patient, and no other condition that could explain the heart rhythm disturbances was diagnosed. The reporting odds ratio was 3.2 (95% confidence interval, 1.0–10.5). The reporting rate was 2 cases per 100,000 patients treated per year (95% confidence interval, 0.4–6.0). These results suggest a causal relationship between rupatadine and heart rhythm disturbances.