Alfonso Moreno

Effect of adverse drug reactions on length of stay in surgical intensive care units.

ObjectiveTo determine the frequency of adverse drug reactions in surgical intensive care units and evaluate their effect on the length of stay. DesignProspective cohort study. Between May 1997 and December 1999, while the patients were staying in the surgical intensive care unit, data were gathered regarding suspected adverse drug reactions and on different variables related to the length of stay. SettingSurgical intensive care units of our hospital. PatientsA total of 401 patients hospitalized in the surgical intensive care unit. Main ResultsIn 37 of the 401 patients seen (9.2%; 95% confidence interval, 6.6–12.5), 39 different adverse drug reactions were detected. The adverse drug reactions were most frequently caused by the following drugs: morphine hydrochloride (n = 13), meperidine hydrochloride (n = 9), and metamizole (n = 7). Five adverse drug reactions were severe, the suspected medication had to be discontinued in 14 cases, and new drugs were necessary to manage the adverse drug reaction in 28 cases. The crude estimation of the effect of adverse drug reactions performed on the length of stay with a bivariant regression model indicated that each adverse drug reaction was related to an increase of 3.39 days (95% confidence interval, 1.47–5.31) in the length of stay. This estimation was reduced to 2.31 days (95% confidence interval, 0.64–3.99) when considering other variables that might cause confusion for analysis, although it is still important. ConclusionsAdverse drug reactions are a significant clinical and economic problem in surgical intensive care units.

Use of albumin in two Spanish university hospitals

AbstractObjectives: The aim of this study was to characterize the use of seralbumin, evaluating how appropriate its prescription is and what possible economic repercussions may result from inappropriate use. Methods: We performed a prospective study that included all patients receiving albumin in two University Hospitals from October 1995 to March 1996. The reasons for albumin use were considered appropriate if they coincided with the recommendations of a panel of experts. Results: During the study period, 197 patients received albumin and a total of 3208 50-ml vials (20%) were used. The internal medicine and gastroenterology services prescribed this drug the most often. The most frequent prescription motives were paracentesis in cirrhotic patients (25.9%), hypoalbuminemia (24.9%) and chronic handling of cirrhotic patients (18.6%). Only 16 prescriptions (8.1%) (corresponding to 315 vials, 9.8%) were considered appropriate. One cause of inappropriate prescribing was that colloid solutions had not previously been used in 56 (30.9%) of the 186 inappropriate prescriptions. During the study period, 74 306 ECUs were spent on inappropriate indications. Conclusions: The use of albumin in our centers is incorrect and has important economic repercussions. Some educational and informative measures must be established to change this situation.

Effect of Drug Interactions on the Development of Adverse Drug Reactions

SummaryAlthough the negative effects of drug interactions are of major theoretical importance, there is only limited information establishing a general relationship between the simultaneous administration of potentially interacting drugs and a higher incidence of adverse drug reactions (ADRs). From 1985 to 1993 we carried out a prospective study of ADR identification in Cardiology and Internal Medicine patients, after which all prescriptions were evaluated in order to search for any potential interactions. A total of 292 ADRs (1.9% over 15 415 prescriptions) were identified during the hospital stay, affecting 232 patients (11.1% over 2093 patients). 59 ADRs (20.2%) were due to the joint action of various drugs. In all, 1660 (10.77%) potential interactions were found (10.8% over 15 415 prescriptions) in 531 different patients (25.4% over 2093 patients). We were able to observe a progressive and significant increase in the crude ‘odds ratio’ of adverse reactions, proportional to the increase in potential interactions (1.42 for 1 interaction, 2.31 for 2 interactions, 2.9 for 3 interactions, and 3.13 for more than 3 interactions, p < 0.00001). We could also detect an increase in the estimated ‘odds ratio’ (adjusted, following a logistic regression model, by number of drugs used in the hospital, use of cardiovascular drugs, use of drugs active upon the nervous system and age of the patient) proportional to the amount of potential interactions (1.26 for 1 interaction, 1.94 for 2 interactions, 2.38 for 3 interactions, 2.24 for more than 3 interactions, p logistic model < 0.0001). On the basis of these results, we conclude that drug interactions are an important cause of ADRs.

Asociación entre consumo de antiinflamatorios no esteroideos e insuficiencia cardíaca congestiva

Fundamento y objetivo Estimar la asociacion entreel consumo previo de antiinflamatorios no esteroideos(AINE) y el ingreso hospitalario debido a insuficienciacardiaca congestiva (ICC), y evaluar elefecto de los inhibidores selectivos de la ciclooxigenasa2 (COX-2) en esta descompensacion. Pacientes y metodo Estudio de casos y controles:982 casos de ICC y 788 controles con antecedentesde ICC, que ingresaron en 10 hospitalesde Madrid. Resultados El uso de AINE (distintos de aspirinaa dosis bajas) se asocio con un aumento delriesgo de ingreso hospitalario por ICC (odds ratio[OR] bruta = 1,59; intervalo de confianza[IC] del 95%, 1,20–2,09; OR ajustada = 1,40;IC del 95%, 1,03–1,90). Conclusiones En individuos susceptibles, elconsumo de AINE supone un aumento del riesgode ingreso por ICC.

Comparative Single-Dose Bioavailability Study of Two Oral Formulations of Ibuprofen in Healthy Volunteers

AbstractObjective: To compare the bioavailability of equivalent doses of two oral formulations of ibuprofen: ibuprofen lysinate 1025mg (powder for oral suspension) and ibuprofen free acid 600mg (effervescent granules). Design and Setting: Nonblind, comparative, two-way, crossover, randomised design carried out in a phase I study unit. Participants: 24 healthy volunteers (10 males, 14 females) with mean age 23.42 years, mean bodyweight 65.38kg, mean height 170.75cm and mean body mass index 22.31 kg/m2. Interventions: During each study period, a single oral dose of one of the formulations was administered, and 15 plasma samples were obtained to determine ibuprofen concentrations and calculate kinetic parameters. Results: The kinetic parameters [ibuprofen lysinate vs ibuprofen free acid (mean ±SD)] were: area under the concentration-time curve from zero to infinity (AUC0-∞) 181.64 ± 64.84 vs 176.99 ± 62.35 mg·h/L; maximum plasma concentration (Cmax) 62.03 ± 9.66 vs 51.39 ± 12.84 mg/L; time to reach Cmax (tmax) [median] 0.54 vs 1.75h. The 90% confidence intervals (CIs) of the ratios of logarithmically transformed values were 98.05 to 107.79% for AUC0-∞ and 112.87 to 137.07% for Cmax; the 90% CI of the difference in tmax was −1.5 to −1.0h. Conclusions: The extent of ibuprofen absorption is the same with both formulations. The speed of release/absorption is greater with the lysinate formulation. This is of particular significance for achieving a rapid analgesic or antipyretic effect.

Pharmacokinetic Study of a New Ibuprofen 600mg plus Codeine 30mg Combination versus Ibuprofen or Codeine Alone in Single Oral Doses in Healthy Volunteers

AbstractObjective: To compare the bioavailability parameter values of ibuprofen 600mg or codeine 30mg when administered in a new combined solid oral formulation versus each agent administered alone. Design: Non-blind, comparative, crossover, three-way (ibuprofen, codeine, ibuprofen plus codeine) randomised clinical trial. Setting: Phase 1 study unit. Subjects: 24 healthy volunteers of both genders (12 males and 12 females) with the following average characteristics: age 22.6 years; bodyweight 63.2kg; height 171cm; body mass index 21.47 kg/m2. Interventions: During each study period, a single oral dose of one of the formulations was administered, and 13 plasma samples were obtained to determine drug concentrations and calculate pharamcokinetic parameter values. Results: The pharmacokinetic parameter values [mean ± standard deviation, except median for time to maximum plasma concentration (tmax)] calculated for each drug and formulation were as follows: For ibuprofen (combined with codeine) versus ibuprofen alone: area under the concentration-time curve from time zero to infinity (AUC0-∞), 202.06 ± 43.62 vs 204.19 ± 52.79 mg·h/L; maximum plasma concentration (Cmax), 64.93 ± 11.91 vs 57.01 ± 15.47 mg/L; tmax, 1.00 vs 1.50h. The 90% confidence intervals (CI90) of the ratios (%) of logarithmically transformed values were: AUC0-∞ 95.88 to 104.22; Cmax 104.75 to 129.63; the CI90 (Wilcoxon test) of the median difference in tmax was −0.80 to −0.13h. For codeine (combined with ibuprofen) versus codeine alone: AUC0-∞ 417.82 ±115.55 vs 354.36 ±114.43 μg·h/L; Cmax115.12 ± 38.85 vs 89.05 ± 27.09 μg/L; tmax 1.00 vs 1.00h. The CI90 of the ratios (%) of logarithmically transformed values were: AUC0-∞ 111.84 to 126.18; Cmax 116.66 to 139.57; the CI90 (Wilcoxon test) of the median difference in tmax was −0.25 to 0.17h. Conclusions: The rate and extent of ibuprofen release/absorption from both formulations are within bioequivalence limits. The extent of absorption of codeine is slightly greater from the combination form, with a similar rate of release/absorption. The slight differences found are attributable to the galenic formulations. These results confirm the good bioavailability of ibuprofen and codeine from the new formulation, and exclude any impairment of absorption when the drugs are formulated in combination.

Adverse Drug Reactions in a Cardiology Department

SummaryAdverse drug reactions (ADRs) pose an important problem in most healthcare areas. However, their importance in cardiology services has not previously been clearly quantified. Between 1985 and 1993, we performed a prospective observational study to evaluate the importance of ADRs in patients admitted to a cardiology department. Of the 1023 patients studied, 11 (1.1%) had an adverse reaction at the time of hospitalisation and 132 (12.9%) had at least one ADR while hospitalised. Ten of 11 ADRs at the time of hospitalisation were the reason for hospitalisation. A total of 178 (2.6% of the 6801 prescriptions) adverse reactions were detected during hospitalisation. The most frequently encountered adverse reactions were nonspecific gastrointestinal problems (n = 34) and headache (n = 33). Digoxin was the drug most frequently implicated in patients hospitalised because of ADRs. Nitrates, calcium antagonists, β-adrenoceptor antagonists and digitalis compounds were the drug classes most frequently associated with ADRs during hospitalisation. The length of hospital stay was almost 5 days longer in patients who developed ADRs during hospitalisation than in those who did not. ADR patients consumed 2.5 more drugs than non-ADR patients. Thus, ADRs during, or leading to, hospitalisation in patients in cardiology departments are associated with important health and economic consequences.

Glioma del quiasma óptico en niños: complicaciones endocrinológicas en 14 casos

BACKGROUND AND OBJECTIVES To describe the frequency of endocrine disorders in children with optic chiasm glioma and analyze related factors. PATIENTS AND METHODS Review of medical records by collecting sex, age, history of neurofibromatosis, clinical presentation, treatment of tumour, and presence of endocrine abnormalities. Statistical tests Wilcoxon and Fisher. RESULTS 14 patients (6 female) with age at diagnosis of 0.5 to 7.0 years (mean±standard deviation: 2.97±2.32) and follow-up of 10.64±3.30 years (range 6.0 to 16.0). 12/14 presented endocrinopathy at follow-up: 8 precocious puberty, 5 hypopituitarism, and 5 obesity. The onset of deficits was related to the neuroophthalmological symptoms under the age of five (P=.02)and treatment of the tumour was required.(P=.03). CONCLUSIONS Children with optic chiasm gliomas may present endocrine disorders from the time of diagnosis of the tumor and, in particular as they develop on. The most common of these is precocious puberty. Pituitary deficits are associated with more aggressive tumours (those presenting with neuroophthalmological signs and symptoms before the age of five and requiring treatment).

Modification of Albumin Use Pattern After an Educational Intervention

AbstractObjective: To determine whether an educational programme could reduce the inappropriate use of albumin. Study design and setting: A hospital albumin working group (San Carlos Clinical Hospital, Madrid, Spain) developed local guidelines for albumin prescribing. After the guidelines were disseminated, all albumin prescriptions were analysed according to these guidelines. Physicians who prescribed albumin for indications other than those in the guidelines were selected for a personalised face-to-face educational programme with a clinical pharmacologists. Adherence to the guidelines was then evaluated compared with an observational period with success being measured in terms of quality of prescribing and economic consequences. The effects of the intervention were assessed again during the intervention (7 months) and after the intervention (in the first 5-month period and in the subsequent year). Main outcomes measures and results: In the observational period, consumption was centralised in medical services and nearly 76% of prescriptions for albumin were inappropriate. During the intervention, the percentage of inappropriate albumin prescribing decreased to 38.8%. Albumin consumption decreased from 444 vials/month during the observational period to 249 vials/month during the intervention, and although the average monthly consumption increased slightly during the 17 months following the intervention, it was similar to that immediately after the intervention.Differences in albumin consumption and quality improvement between the observational period and during the intervention were statistically significant (p < 0.00001). These results led to cost savings of nearly 30% during the intervention and in the follow-up period. Conclusions: This educational programme improved the quality of albumin prescribing and controlled local expenses related to albumin use in a general hospital.

Use of Intravenous Omeprazole in a University Hospital

Objective: To evaluate the characteristics of using intravenous omeprazole in a university hospital. Method: A prospective follow-up of all patients (n = 108) treated with intravenous omeprazole in our hospital was done from October 1994 through May 1995. Based on requests sent to the pharmacy service, patients receiving this drug were located and their charts were reviewed. The patients were visited daily throughout the duration of their treatment to evaluate any change in dosage, addition of new drugs to the regimen, and the final date of treatment. Results: Only 52% of the patients received omeprazole for indications in which its usefulness is clearly demonstrated. The dosages used frequently exceeded those recommended by the pharmaceutical manufacturer and in the literature. In fact, more than 50% of the patients were treated with dosages over 40 mg/d. It would have been possible to administer omeprazole orally instead of intravenously in 17% of the patients. Twenty-three percent of the patients were treated simultaneously with omeprazole and histamine2-antagonists. Conclusions: The use of intravenous omeprazole in our hospital is not optimal; thus, it seems that a strategy to improve this situation should be designed.