ObjectiveTo describe and analyse hospitalisations for adverse drug reactions (ADRs) involving anticoagulants. We also analysed the progress of the reactions over time, the factors related with ADRs.DesignA retrospective, descriptive, epidemiological study.SettingThis study used the Spanish National Hospital Discharge Database (Conjunto Mínimo Básico de Datos, CMBD), over a 4-year period.ParticipantsWe selected CMBD data corresponding to hospital discharges with a diagnosis of ADRs to anticoagulants (International Classification of Diseases-Ninth Revision, Clinical Modification (ICD-9-CM) code E934.2) in any diagnostic field during the study period.Main outcome measuresWe calculated the annual incidence of ADRs to anticoagulants according to sex and age groups. The median lengths of hospital stay and in-hospital mortality (IHM) were also estimated for each year studied. Bivariate analyses of the changes in variables according to year were based on Poisson regression. IHM was analysed using logistic regression models. The estimates were expressed as ORs and their 95% CI.ResultsDuring the study period, 50 042 patients were hospitalised because of ADRs to anticoagulants (6.38% of all ADR-related admissions). The number of cases increased from 10 415 in 2010 to 13 891 in 2013. Cumulative incidence of ADRs to anticoagulants was significantly higher for men than women and in all age groups. An adjusted multivariate analysis revealed that IHM did not change significantly over time. We observed a statistically significant association between IHM and age, with the highest risk for the ≥85 age group (OR 2.67; 95% CI 2.44 to 2.93).ConclusionsThe incidence of ADRs to anticoagulants in Spain increased from 2010 to 2013, and was significantly higher for men than women and in all age groups. Older patients were particularly susceptible to being hospitalised with an adverse reaction to an anticoagulant.
Background and importance Regorafenib (REG) and trifluridine-tipiracil (TAS-102) are used in metastatic colorectal cancer (mCRC) after failure of conventional therapy based on fluorouracil (5-FU) schemes. Aim and objectives To evaluate the efficacy and safety of TAS-102 and regorafenib drugs in patients with mCRC. Material and methods A retrospective single centre study was conducted from January 2010 to August 2020, which included all patients diagnosed with CRBM treated with TAS-102/REG. Clinical and demographic variables were collected, corresponding to age, sex, time of disease follow-up, time of treatment with the drug, previous adjuvant/neoadjuvant, presence of RAS type mutation and number of previous metastatic lines.Efficacy was determined by calculating progression free survival (PFS) applying the Kaplan-Meyer statistic with SPSS V.15. Progression was analysed according to the radiological criteria response evaluation criteria in solid tumours (RECIST V.1.1). The occurrence of grade III/IV adverse effects (AEs) leading to early dose reduction/suspension of treatment was determined. AEs were classified according to the common terminology criteria for adverse effects (CTCAE V.6.0). Results 104 patients were included, 57.7% (n=60) treated with REG (66.3%, n=69); mean age was 63.9 years (41-83)). Mean follow-up time of the disease was 3.9 years (0.1-15.5). Mean duration of treatment was 3.9 months for TAS-102 and 4.2 for REG. 46% (n=48) of patients received adjuvant therapy and 16.3% (n=17) neoadjuvant. 48.1% presented RAS mutation (n=50). Mean of previous metastatic lines was 2.4 (1-7). 84% (n=37) of patients progressed with TAS-102 versus 72% (n=43) with REG. 11.5% (n=12) discontinued treatment due to toxicity. Median PFS was the same for both: 3.8 months (p=0.86). A reduction in drug doses due to the appearance of AEs was carried out in 25% of cases (n=11) with TAS-102 versus 61.7% with REG (n=37). The most common grade III/IV AEs with TAS-102 were haematological toxicity (20.5%, n=9), gastrointestinal (2.3%, n=1) and other (2.3%, n=1); for REG, gastrointestinal (16.7%, n=10), asthenia (13.3%, n=8), skin toxicity (11.7%, n=7), mucositis (6.7%, n=4), plaquetopenia (3.3%, n=2) and other (13.3%, n=8). Conclusion and relevanceThe study showed that there were no significant differences between PFS values between TAS-102 and REG. However, treatment with REG was tolerated worse, with AEs in more than 60% of cases compared with 25% with TAS-102.
BackgroundOne activity of the Hospital Pharmacist is the monitoring and adjustment of nutritional support in hospitalised patients.PurposeTo describe the interventions of the Pharmacy Service in the adjustment of Parenteral Nutrition (PN) in patients hospitalised in a postoperative intensive care unit.Material and methodsRetrospective six-month study. All pharmaceutical care for patients being treated with TPN were recorded in the electronic patient medical record and in an Excel database.ResultsPN was initiated in 40 patients. 29 cases of postsurgical paralytic ileus, 6 peritonitis and 5 gastrointestinal bleeding.All patients were interviewed and were screened to estimate the prior nutritional status. We also considered the presence of stress factors and based on all these factors, we estimated our patients’ caloric and protein requirements.During this period 442 interventions were performed. A median of 11 interventions per patient was described:Detect food allergy (n = 4, 1%)Prevent refeeding syndrome: start nutritional support with 25% of caloric requirements and 100% of micronutrients and electrolytes in patients with moderate to severe malnutrition (n = 48, 11%).Adjust the ratio of non-protein kilocalories/gram of nitrogen to be 80–100 to achieve protein anabolism (n = 80, 18%).Skew caloric intake in favour of lipids in patients with respiratory distress (n = 30, 7%).Restrict lipids in hypertriglyceridemia (n = 14, 3%).Prevent and treat hepatobiliary complications (lipid restriction, nutrition cycling). (n = 22, 5%).Restrict carbohydrates in hyperglycaemia (n = 18, 4%).Administer glutamine and Omega 3 fatty acids according to hospital protocol (n = 60, 14%).Correct electrolyte imbalances. (n = 136, 31%).Restrict fluids and electrolytes in nephropathy and heart disease (n = 26, 6%).ConclusionThese results show a high demand for pharmaceutical attention in patients with TPN.Incorporation of the pharmacist in this unit makes it possible to monitor patient nutrition during hospitalisation.References and/or AcknowledgementsNo conflict of interest.
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