[Comparison of quality of life in patients living with HIV infection through pharmaceutical care according to CMO methodology vs. conventional follow-up. MAS-VIH project]. / Comparación de la calidad de vida en personas que viven con infección por VIH en seguimiento mediante atención farmacéutica según metodología capacidad motivación-oportunidad vs. seguimiento convencional. Proyecto MAS-VIH.

OBJECTIVE: To compare quality of life, in patients living with HIV infection with pharmaceutical care according to the CMO methodology: capacity, motivation and opportunity versus conventional follow-up. METHODS: Longitudinal, prospective, multicenter, health intervention study, conducted between October 2019 and November 2021 in 14 centers throughout Spain. Patients over 18 years of age, receiving antiretroviral treatment and attending the consultations of the participating Pharmacy Services for 1 year were included. Patients who did not have the autonomy to complete the planned questionnaires were excluded. At baseline, participating centers were randomized to continue using the same systematics of work (traditional follow-up) or to implement the CMO model using patient stratification models, goal setting in relation to pharmacotherapy, use of motivational interviewing, as well as longitudinal follow-up enabled by new technologies. The main variable was the difference in the number of dimensions positively affected in each follow-up arm at 24 weeks of follow-up according to the MOS-HIV questionnaire. In the CMO group, the interventions performed the most frequently were recorded. RESULTS: 151 patients were included. The median age was 51.35 years. A significant improvement in quality of life was found at the end of follow-up in the CMO group, reducing the number of patients with negatively affected dimensions (2/11 vs 8/11). The most frequent interventions carried out in the CMO group, according to the taxonomy, were Motivation (51,7%) and review and validation (49,4%). CONCLUSIONS: The quality of life of patients is higher in those centers that develop Pharmaceutical Care based on the CMO methodology compared to traditional follow-up.

Cost-Analysis of Subcutaneous vs Intravenous Administration of Natalizumab Based on Patient Care Pathway in Multiple Sclerosis in Spain.

INTRODUCTION: A subcutaneous (SC) formulation of natalizumab has been recently authorised for multiple sclerosis patients. This study aimed to assess the implications of the new SC formulation, and to compare the annual treatment costs of SC versus intravenous (IV) natalizumab therapy from both the Spanish healthcare system (direct health cost) and the patient (indirect cost) perspectives. METHODS: A patient care pathway map and a cost-minimisation analysis were developed to estimate SC and IV natalizumab annual costs over a 2-year time horizon. Considering the patient care pathway and according to natalizumab experience (IV) or estimation (SC), a national expert panel involving neurologists, pharmacists, and nurses provided information/data regarding resource consumption for drug and patient preparation, administration, and documentation. One hour of observation was applied to the first six (SC) or 12 (IV) doses, and 5 min for successive doses. The Day hospital (infusion suite) facilities at a reference hospital were considered for IV administrations and the first six SC injections. For successive SC injections, either a reference hospital or regional hospital in a consulting room was considered. Productivity time associated with travel (56 min to reference hospital, 24 min to regional hospital) and waiting time pre- and post-treatment (SC 15 min, IV 25 min) were assessed for patients and caregivers (accompanying 20% of SC and 35% of IV administrations). National salaries for healthcare professionals were used for cost estimation (€, year 2021). RESULTS: At years 1 and 2, total time and cost savings (excluding drug acquisition cost) per patient, driven by saving on administration and patient and caregiver productivity for SC at a reference hospital versus IV at a reference hospital, were 116 h (a reduction of 54.6%) and €3682.82 (a reduction of 66.2%). In the case of natalizumab SC at a regional hospital, the total time and cost saving were 129 h (a reduction of 60.6%) and €3883.47 (a reduction of 69.8%). CONCLUSIONS: Besides the potential benefits of convenient administration and improving work-life balance, as suggested by the expert panel, natalizumab SC was associated with cost savings for the healthcare system by avoiding drug preparation, reducing administration time, and freeing up infusion suite capacity. Additional cost savings could be derived with regional hospital administration of natalizumab SC by reducing productivity loss.

Past and future of HIV infection. A document based on expert opinion.

HIV infection is now almost 40 years old. In this time, along with the catastrophe and tragedy that it has entailed, it has also represented the capacity of modern society to take on a challenge of this magnitude and to transform an almost uniformly lethal disease into a chronic illness, compatible with a practically normal personal and relationship life. This anniversary seemed an ideal moment to pause and reflect on the future of HIV infection, the challenges that remain to be addressed and the prospects for the immediate future. This reflection has to go beyond merely technical approaches, by specialized professionals, to also address social and ethical aspects. For this reason, the Health Sciences Foundation convened a group of experts in different aspects of this disease to discuss a series of questions that seemed pertinent to all those present. Each question was presented by one of the participants and discussed by the group. The document we offer is the result of this reflection.

Síndrome del hombre rojo en pediatría: a propósito de 2 casos / Syndrome of the red man in pediatrics: a report of 2 cases

Describimos dos casos de aparición de síndrome de hombre rojo o cuello rojo (SHR) en población pediátrica, una lactante de 3 meses y un niño de 12 años. En ambos pacientes se sustituyó vancomicina por otro glucopéptido, teicoplanina, sin haberse presentado este síndrome en ninguna de sus administraciones a pesar de la semejanza estructural existente entre ambos fármacos. (AU)

We describe two cases of red man or red neck syndrome (RRS) appearance in paediatric population, an infant of 3 months and a child of 12 years. In both patients vancomycin was replaced by another glycopeptide, teicoplanin, without this syndrome having occurred in any of their administrations despite the structural similarity between two drugs. (AU)

Cost-effectiveness analysis of treatment sequences containing tofacitinib for the treatment of rheumatoid arthritis in Spain.

OBJECTIVE: To assess the cost-effectiveness of tofacitinib-containing treatment sequences versus sequences containing only standard biological therapies in patients with moderate-to-severe rheumatoid arthritis (RA) after the failure of conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR population) and in patients previously treated with methotrexate (MTX) who show an inadequate response to second-line therapy with any tumour necrosis factor inhibitor (TNFi-IR population). METHODS: A patient-level microsimulation model estimated, from the perspective of the Spanish Public NHS, lifetime costs and quality-adjusted life years (QALY) for treatment sequences starting with tofacitinib (5 mg twice daily) followed by biological therapies versus sequences of biological treatments only. Concomitant treatment with MTX was considered. Model's parameters comprised demographic and clinical inputs (initial Health Assessment Questionnaire [HAQ] score and clinical response to short- and long-term treatment). Efficacy was measured by means of HAQ score changes using mixed treatment comparisons and data from long-term extension (LTE) trials. Serious adverse events (SAEs) data were derived from the literature. Total cost estimation (€, 2018) included drug acquisition, parenteral administration, disease progression and SAE management. RESULTS: In the csDMARD-IR population, sequences starting with tofacitinib proved dominant options (more QALYs and lower costs) versus the corresponding sequences without tofacitinib. In the TNFi-IR population, first-line treatment with tofacitinib+MTX followed by scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX proved dominant versus scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX; and tofacitinib+MTX➔scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX versus scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX was less effective but remained a cost-saving option. CONCLUSIONS: Inclusion of tofacitinib seems a dominant strategy in moderate-to-severe RA patients after csDMARDs failure. Tofacitinib, as initial third-line therapy, proved a cost-saving strategy (€- 337,489/QALY foregone) in moderate-to-severe TNFi-IR RA patients. Key points • Therapeutical approach in rheumatoid arthritis (RA) consisted in sequences of several therapies during patient lifetime. • Treatment sequences initiating with tofacitinib followed by biological drugs provided higher health effects in csDMARDs-IR population, compared with sequences containing only biological drugs. • In both csDMARD-IR and TNFi-IR RA populations, initiating treatment with tofacitinib was associated to lower treatment costs for the Spanish National Health System.

The Cost of Psoriasis and Psoriatic Arthritis in 5 European Countries: A Systematic Review. / Coste de la psoriasis y artritis psoriásica en cinco países de Europa: una revisión sistemática.

INTRODUCTION: While the introduction of biologics has improved the quality of life of patients with psoriasis and psoriatic arthritis, it may have increased the economic burden of these diseases. OBJECTIVE: To perform a systematic review of studies on the costs associated with managing and treating psoriasis and psoriatic arthritis in 5 European countries: Germany, Spain, France, Italy, and the United Kingdom. METHODS: We undertook a systematic review of the literature (up to May 2015) using the MEDLINE and EMBASE databases. The methodological quality of the studies identified was evaluated using the Consolidated Health Economic Evaluation Reporting Standards checklist. We considered both direct costs (medical and nonmedical) and indirect costs, adjusted for country-specific inflation and converted to international dollars using purchasing power parity exchange rates for 2015 ($US PPP). RESULTS: The search retrieved 775 studies; 68.3% analyzed psoriasis and 31.7% analyzed psoriatic arthritis. The total annual cost per patient ranged from US $2,077 to US $13,132 PPP for psoriasis and from US $10,924 to US $17,050 PPP for psoriatic arthritis. Direct costs were the largest component of total expenditure in both diseases. The severity of these diseases was associated with higher costs. The introduction of biologics led to a 3-fold to 5-fold increase in direct costs, and consequently to an increase in total costs. CONCLUSIONS: We have analyzed the economic burden of psoriasis and psoriatic arthritis and shown that costs increase with the treatment and management of more severe disease and the use of biologics.

[Cardiovascular risk and metabolic syndrome at the Toledo Area Study]. / Riesgo cardiovascular y síndrome metabólico en el Estudio Area de Toledo.

OBJECTIVES: To know the anthropometric and clinical characteristics of a children population sample, to study the prevalence and concurrence of cardiovascular risk factors in that sample, and to define the prevalence of metabolic syndrome in that population considering the blood pressure, HDL cholesterol, and fasting glycemia values, as well as the anthropometrical measurements. SETTING: The health care area of Toledo. SUBJECTS: Children aged 4 years included in the Toledo Area Study. INTERVENTIONS: A prospective study is performed on the metabolic syndrome-related cardiovascular risk factors in a sample of 58 children from the Toledo Area Study. Data on anthropometrical and lipoprotein profile at birth were obtained. The anthropometrical, lipoprotein, and biochemical data were compared with those from other populations; we also looked for possible differences between boys and girls. At the same time, we analyzed the association between several cardiovascular risk factors in that population (logistic regression model) and we set up the cut-off levels to define in the children population possible candidates to metabolic syndrome. These levels are in agreement with those from similar adolescent populations. RESULTS: Among the risk factors, higher systolic and diastolic pressure values stand up in girls (93.93 -boys- vs 98.41 -girls- p = 0.058; 52.32 -boys- vs 57.27 -girls- p = 0.026, respectively), as well as the concurrence of high blood pressure and hypercholesterolemia in boys (almost 7%). The whole prevalence of candidates to MS was 10.9% (5 girls -9.1%- and 1 boy -1.8%-). A high percentage of boys (< 50%) presented a wrong diet from the perspective of dietary cardiovascular risk markers. The only statistically significant variable at 10% (p < 0.10) in the regression model was Apo AI. CONCLUSIONS: It is relevant that the presence of MS is higher in girls and in those infants with a dyslipemic nonhypercholesterolemic profile at birth, which emphasizes the usefulness of cardiovascular risk factors prospection from early ages.

[Retrospective analysis of the carboplatin dosage and relationship with toxicity in cancer patients]. / Análisis retrospectivo de la dosificación de carboplatino y relación con su toxicidad en pacientes oncológicos.

OBJECTIVE: To analyse carboplatin dosage in cancer patients in order to establish whether they are over- or underdosed in comparison to the theoretical dose calculations during the first cycle of chemotherapy and to find a relationship between the dosage in the first cycle and dose reduction in subsequent cycles, as a result of adverse effects related to the same. METHOD: Retrospective analysis over a one year period of prescriptions of chemotherapy with carboplatin. Patients were stratified into 4 groups according to body mass index and serum creatinine values. The mean percent error (MPE) was used to determine the relationship between the dose received and the theoretical dose calculation during the first cycle. The Mann-Whitney U test was used to study the possible relationship between patients dosage during the first cycle and dose reduction in subsequent cycles. RESULTS: A total of 86 patients were selected. Only the cohort of patients who were overweight/obese showed significant differences between the theoretical dose calculation and the dose actually received. The mean MPE value with the standard error for this group was 7.963 +- 2.610%. No links were found with the dose reduction in subsequent cycles for this cohort of patients. CONCLUSIONS: Not using adjusted weight or serum creatinine values in the Cockcroft-Gault equation may lead to incorrect doses of carboplatin in obese patients. Studies including a larger number of patients are required to confirm the relationship between overdosing during the first cycle and dose reduction in subsequent cycles, as a result of carboplatin toxicity.