Adverse drug reactions in paediatric surgery: prospective study on frequency and risk related factors.

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.

[Changes in the pattern of use of non-conventional amphotericin B after the implementation of a training intervention at the San Carlos Clinical Hospital of Madrid]. / Modificación en el patrón de uso de Anfotericina B no convencional tras la puesta en marcha de una intervención Formativa en el Hospital Clínico San Carlos de Madrid.

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.

[Use of non-conventional amphotericin B at the San Carlos Clinical Hospital]. / Utilización de anfotericina B no convencional en el hospital clínico de San Carlos.

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.

[Peritoneal mesothelioma and complete auriculo-ventricular block as late complications in Hodgkin's disease]. / Mesotelioma peritoneal y bloqueo aurículo-ventricular completo como complicaciones tardías de la enfermedad de Hodgkin.

A patient who had been successfully treated of Hodgkin's disease (nodular sclerotic type) with mediastinal radiotherapy and polychemotherapy, suffered an acute pericarditis immediately after radiotherapy and a complete atrial-ventricular block 14 years later. Five years later she presented refractory hemorrhagic peritonitis. Necropsy study showed a peritoneal mesothelioma (in non radiated area) and diffuse subpericardial fibrosis. Complete A-V block is a very rare late complication of mediastinal radiotherapy and mesotheliomas (almost exclusively in irradiated areas), also. We have not found any reports on other cases of peritoneal mesotheliomas not attributable to radiotherapy as second neoplasia in Hodgkin's disease.