[Impact of a primary care pharmacy unit on the optimization of pharmacological treatment of type 2 diabetic patients]. / Impacto de una unidad de farmacia de atención primaria en la optimización del tratamiento farmacológico de pacientes diabéticos tipo 2.

OBJECTIVE: To evaluate the impact of a pharmaceutical intervention on treatment optimization in patients with type 2 diabetes mellitus. DESIGN: Before-after intervention study. SITE: Health centers of the Primary Care Department of Camp de Tarragona. PARTICIPANTS: Patients aged ≥ 18 years, diagnosed with type 2 diabetes mellitus and under treatment with antidiabetic drugs. INTERVENTIONS: Review of pharmacological treatment for type 2 diabetes mellitus and issuance of proposals for its adequacy. MAIN MEASUREMENTS: Demographic and clinical variables were collected to assess the adequacy of antidiabetic treatment. A consensus meeting was arranged with the patients' primary care physician to evaluate the proposals for improvement. The implementation of the proposals and the variation in postintervention glycemic control were assessed. RESULTS: A total of 907 patients (59% men) were included. A total of 782 proposals for intervention were made in 65.8% of the patients reviewed. Of the proposals, 43.5% corresponded to drug discontinuation, 16% to intensification of dosing and 12.6% to exchange for a therapeutic equivalent. Of the consensual proposals, 54.7% were implemented. HbA1c was reduced by 0.2% after the intervention (7.4 vs 7.2%). CONCLUSIONS: Review of the pharmacological treatment of patients with type 2 diabetes mellitus by a pharmacist or pharmacologist facilitates its optimization.

Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment.

Acquired thrombocytopenic thrombotic purpura (aTTP) is an autoantibody-mediated disease against the enzyme A Disintegrin and Metalloprotease domain with ThromboSpondin-1 type motif 13, which until now has been treated with plasma exchange (PEX) and corticosteroids. A 29-year-old female patient, who presented with aTTP in the context of pregnancy, has developed multiple relapses after treatment with PEX, corticosteroids, and rituximab. Recently, caplacizumab, a nanobody against von Willebrand factor, has been approved for the treatment of aTTP. In our patient, caplacizumab achieved better disease control, with a lower platelet count restoration time, days of PEX and hospitalization duration, as compared to standard therapy, reproducing the results of clinical trials. Caplacizumab represents a significant advance in the treatment of aTTP, especially in cases of recurrent relapses.

Analysis of chemical contamination by hazardous drugs with BD HD Check® system in a tertiary hospital.

The presence of contamination in the healthcare work environment by one of the types of hazardous drugs, cytostatics, has been found in multiple international studies. Recent studies and guidelines recommend surface monitoring for risk assessment of healthcare professionals' exposure. The availability of detection techniques is critical to successfully carry out this type of monitoring. The use of new semi-quantitative techniques allows quicker results. The main objective of this study was to determine the existence of hazardous drugs on the working surfaces in different locations of a tertiary hospital using the BD HD Check® semi-quantitative device. The presence of methotrexate, doxorubicin and cyclophosphamide was analysed at 80, 89 and 82 locations in 10, 13 and 11 clinical units, respectively. A total of 251 samples were analysed. The monitoring results were positive for 13.1% of the analysed samples, with 36.3% of the methotrexate samples, 0% of the doxorubicin samples and 4.9% of the cyclophosphamide samples. Mapping the presence of HD in our hospital has allowed us to evaluate the effectiveness of controls established in the hospital to minimise the exposure of healthcare professionals to hazardous drugs. The speed in obtaining results has enabled immediate corrective actions in cases where contaminated surfaces were detected.

Knowledge of biological therapy for patients with immune-mediated diseases. BIOINFO Study. / Conocimiento de la terapia biológica en pacientes con enfermedades inmunomediadas. Estudio BIOINFO.

OBJECTIVE: To determine the degree of knowledge about biological therapy and biosimilars in patients with immune-mediated inflammatory diseases treated in Outpatient Pharmaceutical Care Units. METHODS: Observational, prospective and multicenter study during the period May 2020-March 2021. A survey (9 questions) was conducted before starting treatment in which the patients' level of knowledge about biological therapy and biosimilars was assessed. RESULTS: A total of 169 patients were included in the study. The average value for the different questions was 3.3 ± 0.6 out of 5, while the average final result was 29.4 points out of 45. Sixty-four percent of the patients had an acceptable level before starting the medication (>27 points). The multivariate analysis showed a statistically significant correlation (p<0.05) with a better score at the beginning of treatment in those patients whose prescribing service was Rheumatology. CONCLUSIONS: In general, the level of knowledge prior to biological therapy in patients is acceptable, being higher in dosage and administration technique related-factors and what is related to the dosage and administration technique and where to find information related to the medication; the worst rated were those on biosimilars-related. The factor of being followed by rheumatology, was associated with better knowledge.

Analysis of the situation of pharmaceutical care for patients with immune-mediated inflammatory diseases before and after the COVID-19 pandemic. / Análisis de la situación de la atención farmacéutica a pacientes con enfermedades inflamatorias inmunomediadas antes y después de la pandemia COVID-19.

OBJECTIVE: To describe, analyze and compare the situation of pharmaceutical care consultations for outpatients with immune-mediated inflammatory diseases of the Pharmacy Services of Spain at two different times. METHOD: Longitudinal, multicenter and unidisciplinary descriptive observational study, carried out by the Immune-mediated Inflammatory Diseases Working Group of the Spanish Society of Hospital Pharmacy through a virtual survey in 2019 and 2021. Variables were collected regarding coordination, resources, biosimilars, unmet needs and telepharmacy. Numerical results were presented in absolute value and percentage and free text responses were grouped by topic areas. To compare the results between the two collection times, the Chi-Square test was used with a significance level of p<0.05. RESULTS: The level of participation was 70 pharmacists in 2019 and 53 in 2021. The main significant findings obtained were an increase in participation in asthma biologic committees (p=0.044) and care coordination in dermatology (p=0.003) and digestive system (p=0.022). The wide use of biosimilar biological medicines stood out, with a 15% increase in the exchange of the reference biological to the biosimilar. The lack of research in the field and insufficient human resources, among other unmet needs, were revealed. In the outpatient units, the use of the stratification model of the MAPEX project was a minority and an increase in the use of information and communication technologies was promoted. Motivated by the pandemic derived from COVID-19, telepharmacy was established for the first time in 85% of the centers, maintaining the service at 66% at the time of the second survey. CONCLUSIONS: Outpatient units are undergoing constant change to adapt to new times, for which institutional support is needed to invest more resources to promote the development of strategies to reduce unmet needs. We must continue working to achieve a pharmaceutical practice that provides efficiency, safety, quality of life and access to innovative drugs in patients with immune-mediated inflammatory diseases.

Baricitinib against severe COVID-19: effectiveness and safety in hospitalised pretreated patients.

OBJECTIVES: To analyse the effectiveness and safety of baricitinib for severe COVID-19 in cytokine storm syndrome based on its potential role as an anti-inflammatory immunomodulator and inhibitor of viral endocytosis. METHODS: This was an observational retrospective study of hospitalised patients treated with baricitinib for severe COVID-19. Outcomes were clinical improvement on an ordinal scale of 1-8 on day 1 of baricitinib compared with day 14 (where 8=death and 1=not hospitalised with no limitations of activities), overall survival, time to recovery since baricitinib treatment started (days until hospital discharge) and laboratory parameters related to COVID-19 poor prognosis. Adverse events related to baricitinib during the admission period were also reported. RESULTS: Forty-three patients (70% men, mean age 70 years (IQR 54-79)) treated with baricitinib daily for 6 days (IQR 5-7) were included. Thirty-six patients were treated with corticosteroids (84%). Clinical improvement was 3 points (IQR 1-4) in patients on an ordinal scale of 4-6, overall survival was 100% at day 30 and day 60 with a mean time to recovery of 12 days (IQR 9-25) from start of baricitinib treatment. No adverse events of interest were found and all poor prognosis risk factors improved at day 14: interleukin-6, C-reactive protein, ferritin, lymphocytes, platelets and D-dimers. CONCLUSIONS: Patients treated with baricitinib for severe COVID-19 showed improvements in clinical and analytical values without relevant adverse events and 100% overall survival. Clinical randomised trials are needed to confirm the clinical benefit of baricitinib.

Characteristics, clinical outcomes, and risk factors of SARS-COV-2 infection in adult acute myeloid leukemia patients: experience of the PETHEMA group.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection produces higher morbidity and mortality in hematological malignancies, but evidence in acute myeloid leukemia (AML) is scarce. A multicenter observational study was conducted to determine the clinical outcomes and assess the impact of therapeutic approaches in adult AML patients with SARS-CoV-2 infection in the first wave (March-May 2020). Overall, 108 patients were included: 51.9% with active leukemia and 70.4% under therapeutic schedules for AML. Signs and symptoms of SARS-CoV-2 were present in 96.3% of patients and 82.4% received specific treatment for SARS-CoV-2. The mortality rate was 43.5% and was correlated with age, gender, active leukemia, dyspnea, severe SARS-CoV-2, intensive care measures, neutrophil count, and D-dimer levels. A protective effect was found with azithromycin, lopinavir/ritonavir, and normal liver enzyme levels. During the SARS-CoV-2 first wave, our findings suggested an increased mortality in AML in a short period. SARS-CoV-2 management could be guided by risk factors in AML patients.

Involvement of interleukin 6 in SARS-CoV-2 infection: siltuximab as a therapeutic option against COVID-19.

The aim of the study was to explore the involvement of interleukin 6 in SARS-CoV-2 infection, and to position the drug siltuximab in the management of severe forms of COVID-19. A bibliographic search was performed in Pubmed on the immune response to the disease, and in ClinicalTrials.gov on clinical trials with interleukin 6 blockers. Interleukin 6 is involved in the cytokine cascade, which originates as a consequence of an excessive immune response secondary to viral infection, aggravating lung affectation. Blockers of this cytokine (tocilizumab, sarilumab and siltuximab) are being studied as a strategy for treating the disease. Siltuximab is a monoclonal antibody indicated in Castleman's disease that could be administered in a single dose of 11 mg/kg in severe forms of COVID-19 that have increased interleukin 6.

Metyrapone as treatment in the neonatal McCune-Albright syndrome.

Objectives To present a case report of succesfully metyrapone treatment of a neonatal patient with McCune-Albrigth syndrome (MAS), a rare disease caused by a genetically mosaic disorder and is characterized by variable hyperfunctional endocrinopathies, bone dysplasia, and café-au-lait spots. Case presentation A preterm newborn was admitted to hospital and she presented difficulty controlling hypertension, café-au-lait spots, and failure to thrive. An abdominal ultrasound and a magnetic resonance showed a high volume of both suprarenal glands. Therefore, MAS was suspected. Laboratory data confirmed adrenocorticotropic hormone-independent Cushing's syndrome with hepatic dysfunction and metyrapone treatment was initiated. A progressive normalization of cortisol levels was achieved despite poor oral tolerance. Conclusion Our case shows that metyrapone is useful in the management of neonatal Cushing's syndrome due to McCune-Albright syndrome.