ABSTRACT
BACKGROUND: Paediatric patients are especially prone to experiencing adverse drug reactions (ADRs), and the surgical environment gathers many conditions for such reactions to occur. Additionally, little information exists in the literature on ADRs in the paediatric surgical population. We aimed to quantify the ADR frequency in this population, and to investigate the characteristics and risk factors associated with ADR development. METHODS: A prospective observational study was conducted in a cohort of 311 paediatric patients, aged 1-16 years, admitted for surgery at a tertiary referral hospital in Spain (2019-2021). Incidence rates were used to assess ADR frequency. Odds ratios (ORs) were calculated to evaluate the influence of potential risk factors on ADR development. RESULTS: Distinct ADRs (103) were detected in 80 patients (25.7%). The most frequent being hypotension (N = 32; 35%), nausea (N = 16; 15.5%), and emergence delirium (N = 16; 15.5%). Most ADRs occurred because of drug-drug interactions. The combination of sevoflurane and fentanyl was responsible for most of these events (N = 32; 31.1%). The variable most robustly associated to ADR development, was the number of off-label drugs prescribed per patient (OR = 2.99; 95% CI 1.73 to 5.16), followed by the number of drugs prescribed per patient (OR = 1.26, 95% CI 1.13 to 1.41), and older age (OR = 1.26, 95% CI 1.07 to 1.49). The severity of ADRs was assessed according to the criteria of Venulet and the Spanish Pharmacovigilance System. According to both methods, only four ADRs (3.9%) were considered serious. CONCLUSIONS: ADRs have a high incidence rate in the paediatric surgical population. The off-label use of drugs is a key risk factor for ADRs development.
Subject(s)
Drug-Related Side Effects and Adverse Reactions , Humans , Prospective Studies , Child , Child, Preschool , Female , Male , Risk Factors , Infant , Adolescent , Drug-Related Side Effects and Adverse Reactions/epidemiology , Spain/epidemiology , Surgical Procedures, Operative/adverse effects , Incidence , Drug Interactions , Off-Label Use , Emergence Delirium/epidemiology , Emergence Delirium/chemically inducedABSTRACT
This article details the specifications authorised for human use in the clinical practice for the radiopharmaceutical products composed of iobenguane ((123)I) marketed in Spain.
Subject(s)
3-Iodobenzylguanidine , Iodine Radioisotopes , Nuclear Medicine/legislation & jurisprudence , Radiopharmaceuticals , 3-Iodobenzylguanidine/administration & dosage , 3-Iodobenzylguanidine/adverse effects , 3-Iodobenzylguanidine/pharmacokinetics , Adolescent , Adult , Aged , Animals , Child , Contraindications , Dogs , Drug Overdose , Female , Humans , Infant , Infant, Newborn , Iodine Radioisotopes/administration & dosage , Iodine Radioisotopes/adverse effects , Iodine Radioisotopes/pharmacokinetics , Lactation , Legislation, Drug , Male , Middle Aged , Pregnancy , Radiation Injuries/etiology , Radiation Injuries/prevention & control , Radiometry , Radiopharmaceuticals/administration & dosage , Radiopharmaceuticals/adverse effects , Radiopharmaceuticals/pharmacokinetics , Rats , Spain , Young AdultABSTRACT
Este artículo detalla las condiciones de usohumano autorizadas en la práctica clínica para los radiofármacos compuestos de iobenguano (123I) legalmente comercializados en España
This article details the specifications authorisedfor human use in the clinical practice for the radiopharmaceutical products composed of iobenguane (123I) marketed in Spain (AU)
Subject(s)
Humans , Animals , Male , Female , Pregnancy , Infant, Newborn , Infant , Child , Adolescent , Adult , Middle Aged , Aged , Dogs , Rats , Iodine Radioisotopes/administration & dosage , Iodine Radioisotopes/adverse effects , Legislation, Drug , Nuclear Medicine/legislation & jurisprudence , Radiopharmaceuticals/administration & dosage , Radiopharmaceuticals/adverse effects , Lactation , Radiometry , SpainABSTRACT
No disponible
No disponible
Subject(s)
Anticonvulsants/therapeutic use , Epilepsy/drug therapy , Drugs, Generic/pharmacokinetics , Drugs, Generic/therapeutic use , Therapeutic EquivalencyABSTRACT
No disponible
Subject(s)
Animals , Humans , Adverse Drug Reaction Reporting Systems , SpainABSTRACT
Las heparinas de bajo peso molecular han de mostrado ser tan eficaces y seguras en la profilaxis del tromboembolismo venoso como la heparina no fraccionada. Su baja unión a proteínas plasmáticas, macrófagos y endotelio contribuye a su excelente biodisponibilidad vía subcutánea, a una respuesta anticoagulante más predecible cuando se administra a dosis fijas y a una vida media mayor. Además su administración subcutánea es más cómoda para el paciente y no se precisan ajustes de dosis. En este trabajo se revisan los principales factores de riesgo del tromboembolismo venoso y los distintos métodos físicos y farmacológicos disponibles actualmente para prevenirlo. También se resumen las últimas recomendaciones publicadas para la profilaxis del TEV en pacientes no quirúrgicos (AU)
Subject(s)
Female , Male , Humans , Thromboembolism/prevention & control , Heparin, Low-Molecular-Weight/therapeutic use , Risk Factors , Antibiotic Prophylaxis , Myocardial Infarction/etiologyABSTRACT
BACKGROUND: Amphotericin B is the treatment of choice for systemic fungal infections. Among the different AB formulations available, the lipid forms appear to have a better profile of reliability, however, their cost is noticeably higher. In 1999 (pre-initiative period) an evaluation of the quality of the prescription of these preparations was made in our hospital, which revealed that they were not being used to best advantage and were responsible for generating a significant unnecessary expenditure. As a result of this, an information initiative was implemented with respect to the prescribing physicians for the purpose of reducing the inappropriate use of AB. METHOD: The quality of 100 prescriptions was evaluated prospectively, according to the standards of use of Amphotericin B established in the hospital. Following each evaluation, a pharmacologist personally handed over to each prescribing physician a set of rules governing the use of the Amphotericin B, discussing the indication and recommending the best alternative in each case. In order to measure the impact of this initiative, the appropriateness of the prescriptions during this period was compared with the pre-initiative period. RESULTS: The percentage of inappropriate prescriptions dropped from 58% to 21% following the implementation of the initiative. Likewise, a 33-million-peseta reduction in the total expenditure was achieved in 15 months as well as a savings of 24 million in inappropriate prescriptions. CONCLUSIONS: The information initiative improved the quality of the prescribing of preparations of Amphotericin B associated with lipids and considerably reduced the unnecessary expense associated with Amphotericin B misuse in our hospital.
Subject(s)
Amphotericin B/therapeutic use , Antifungal Agents/therapeutic use , Drug Prescriptions/statistics & numerical data , Hospitals, Urban , Humans , Prospective Studies , SpainABSTRACT
BACKGROUND: Amphotericin B is the treatment of choice for systemic fungal infections, however, its clinical usefulness is limited by its toxicity. The lipid formulations appear to be equally effective and safer, but are more costly. The increase in the consumption of, and expenditure on these formulas led us to undertake a study in order to identify their profile of use (quantitative and qualitative) and to assess the financial repercussions when used inappropriately. METHODS: A set of rules were developed for the use of amphotericin B, and the quality of the prescription of non-conventional amphotericin B (amphotericin B notC) was evaluated retrospectively together with the financial repercussions of its inappropriate use. RESULTS: In 54% of the treatments studied, a poor selection of amphotericin B was made; in 3.5%, the use of amphotericin B was not indicated. The excess expenditure derived from the inappropriate use amounted to 42 million pesetas, 35% of the total expenditure on medicines; the expenditure due to unnecessary prescription was 1,720,327 pesetas. CONCLUSIONS: The retrospective evaluation has shown that there is a high percentage of treatments that do not conform with the recommendations contained in the prescription rules. The holding of information sessions would assist in achieving a more efficient selection of the amphotericin B notC; this would improve prescription quality, which might also deliver significant financial savings.
Subject(s)
Amphotericin B/therapeutic use , Antifungal Agents/therapeutic use , Mycoses/drug therapy , Amphotericin B/economics , Antifungal Agents/economics , Chemistry, Pharmaceutical , Drug Costs , Drug Utilization , Humans , Retrospective Studies , SpainABSTRACT
No disponible
Subject(s)
Adult , Female , Humans , 4-Aminopyridine/poisoning , Multiple Sclerosis/complications , Drug Overdose/diagnosisABSTRACT
BACKGROUND: A quantitative and qualitative assessment of reports on suspected adverse drug reactions (ARD) in Spanish medical literature was carried out. MATERIALS AND METHODS: The periods analysed were 1972-1974, 1986-1988 and 1992-1994, and the medical journals were Anales de Medicina Interna, Medicina Clínica and Revista Clínica Española. We selected all articles including specific information on suspect ADR. RESULTS: The percentage of articles has increased considerably (1972-1974: 2.1%, 1986-1988: 5.7%, and 1992-1994: 8.2%). In spite of this growth, the qualitative data studied have not significantly improved. CONCLUSIONS: It is necessary to device some mechanism in order to improve ADR reporting.
Subject(s)
Bibliographies as Topic , Drug-Related Side Effects and Adverse Reactions , Chi-Square Distribution , Female , Humans , Male , Periodicals as Topic/statistics & numerical data , Spain , Statistics, NonparametricSubject(s)
Omeprazole , Chemistry, Pharmaceutical , Humans , Hydrogen-Ion Concentration , Omeprazole/metabolismABSTRACT
Cryptococcosis is the commonest fungal infection of the CNS and it is an important cause of morbidity and mortality in immunodeficient patients [1]. It has been occasionally described in immunocompetent patients [2]. We report a patient with no predisposing factors who was treated with flucytosine and amphotericin B for cryptococcal meningitis. Following treatment, she developed a reversible acute cerebellar syndrome that was probably secondary to the administration of flucytosine, an adverse effect that has not previously been described [3, 4]. An 87-year old women with no relevant personal or family history was admitted to the hospital for headache, fever, and confusion over the past week. The vital signs, general and neurological examination were normal. In laboratory tests, the urine, urea nitrogen, glucose, bilirubin, electrolytes, aspartate aminotransferase, creatine kinase, alkaline phosphatase, haematocrit, white-cell count, and platelet were also normal. A lumbar puncture was performed which showed: 60 typical lymphocytes per ml, adenosine deaminase (ADA) activity 6 U.l-1 (normal under 4 U.l-1), proteins 75.7 mg.dl-1, and glucose 13 mg.dl-1 with a glycaemia of 120 mg.dl-1. The microbiology study showed staining and a positive culture for Cryptococcus neoformans, and an antigen titre of 1/2080. The serology for HIV infection was negative, and other predisposing factors for this fungal infection, such as immunological defects, a lymphoreticular malignancy and sarcoidosis were excluded. A CT scan of the cranial-thoracic-abdominal regions was normal and tumour markers were absent.
Subject(s)
Antifungal Agents/adverse effects , Cerebellar Diseases/chemically induced , Flucytosine/adverse effects , Aged , Aged, 80 and over , Antifungal Agents/therapeutic use , Cryptococcosis/drug therapy , Cryptococcosis/microbiology , Female , Flucytosine/therapeutic use , HumansABSTRACT
The acetylation phenotype was determined, by means of sulfamethazine measurement, in 87 patients (83 male) with confirmed bronchogenic carcinoma and in 93 healthy control patients (41 male) of equal ages. 48 patients and 54 controls were classified as being "slow acetylators" (Ch2 n.s.) When the persons were individually analysed by phenotype, it was confirmed that the patients showed a significantly lower rate of acetylated sulfamethazine than the control group (p less than 0.02), owing to the poor acetylation of patients with small-cell lung cancer. This difference should be confirmed by more detailed pharmacokinetic studies before regarding it as a possible interference of paraneoplasic type. The polymorphism acetylator cannot be considered a genetic marker related to the risk of having lung cancer.
Subject(s)
Arylamine N-Acetyltransferase/genetics , Carcinoma, Bronchogenic/metabolism , Lung Neoplasms/metabolism , Acetylation , Female , Humans , Male , Middle Aged , Polymorphism, GeneticABSTRACT
Almitrine dimesylate is a peripheral respiratory stimulant which is effective both on long and short term treatment of chronic obstructive lung disease. The individual therapeutic response, however, is very variable and approximately 25% of patients might not respond to treatment. The recommended doses are 50-100 mg per day during two months, followed by a resting month. Higher doses or longer treatments could provoke high serum levels which in turn would increase the risk of pulmonary hypertension and peripheral neuropathies. Almitrine is not commercialized in Spain as a single drug or for the cited indications.
