ABSTRACT
Background and ImportanceThe COVID-19 pandemic has highlighted the important role that hospital pharmacists play in improving pharmacotherapy outcomes. Paxlovid® (Nirmatrelvir/ritonavir) was recently granted an Emergency Use Authorisation for the treatment of mild to moderate COVID-19. However, the use of Paxlovid® with certain other drugs in high-risk patients may result in potentially significant drug-drug interactions (DDI) and adverse drug events (ADE).Aim and ObjectivesTo assess the impact of a comprehensive pharmaceutical care program (CPCP) focusing on the prevention of DDI and ADE, initiated in a hospital pharmacy for patients with mild to moderate COVID-19 treated with Paxlovid®.Material and MethodsDesign: Quasi-experimental study performed between 1 May and 31 July 2022. Pharmacists were responsible for proposing COVID-19 local guidelines to physicians, monitoring adherence to guidelines, managing DDI and ADE, providing patient education, and evaluating health outcomes. A telephone consultation was carried out 10 days after the end of Paxlovid® treatment.Potential DDI were detected according to Lexi-Comp® and Liverpool COVID-19 databases. Paxlovid-related ADE reported were graded according to Common Terminology Criteria for Adverse Events, version 4.Results140 patients (60.7% outpatients) initiated Paxlovid® and were enrolled in the CPCP. Adherence to local guidelines for the use of Paxlovid® was 100%.Overall, 232 DDI were detected in 111 (79.3%) patients, 142 (61.2%) of which required specific management (34.5% discontinuation of the concomitant drug and 65.5% dose adjustment).Pharmacists made 267 interventions that led to the prevention of 177 ADE (1.3/patient), 96 (54.2%) of which were grade G-H (NCC MERP classification).At day 10, 96 ADEs were reported in 42 patients (26.1% of which were grade ≥3), being dysgeusia and diarrhoea the most common. Premature discontinuation of Paxlovid® due to ADEs was necessary in 4 (2.8%) patients.Conclusion and RelevanceThe implementation of a CPCP developed by hospital pharmacists for patients treated with Paxlovid® was an effective approach for monitoring adherence to guidelines, managing DDI, providing patient education, and evaluating safety outcomes. Paxlovid® showed an acceptable safety profile.References and/or AcknowledgementsConflict of InterestNo conflict of interest.
ABSTRACT
Objective: To describe the impact of a Specialized Pharmaceutical Care model that includes pharmacotherapeutic monitoring of patients through an Telepharmacy platform and home medication dispensing. Method(s): A descriptive and retrospective study conducted in the Pharmacy Service of a tertiary hospital, between 23 March 2020 and 31 December 2021. A new pharmaceutical care model for chronic ambulatory patients was developed, including: (i) definition of criteria for selecting Telepharmacy candidate patients;(ii) stratification of patients by risk level;(iii) definition of individualized pharmacotherapeutic monitoring;(iv) adaptation of the Pharmacy Service app platform to ensure continuous pharmacotherapeutic monitoring and patient monitoring (e-Oncohealth, e-Midcare and farMcuida), (v) implementation of an appointment system;and (vi) development of a software module for the management of home medication delivery. The impact of this pharmaceutical care model was assessed by analyzing indicators of activity, safety, adherence and perceived quality. Moreover, an additional study on the impact of COVID-19 was developed in order to assess the accessibility of medical care and continuity of treatment through a survey conducted on a random sample of 100 patients. Result(s): During the study period, 2, 737 patients benefited from the new remote pharmaceutical care model. A total of 7, 758 Telepharmacy consultations were performed. Pharmacotherapeutic monitoring prevented 1, 043 adverse drug reactions, which affected 10.4% of patients (3.6 adverse drug reactions/patient). Mean adherence to treatment was 95.2%. Overall satisfaction with the new model was 9.8/10. All patients would recommend this model to other patients. Conclusion(s): The new Pharmaceutical care model increases patient safety and improves treatment adherence, with a high perceived quality. Patient stratification and individualized follow-up via an Telepharmacy platform were crucial to the development of this model. Copyright © 2022 Grupo Aula Medica S.L.. All rights reserved.
ABSTRACT
Background and importance Identification of the angiotensin converting enzyme (ACE2) as a target of the SARS-CoV-2 virus raises questions about a possible change in the clinical course of this infection associated with inhibitors of the renin-angiotensin-aldosterone system (RAAS). Furthermore, high blood pressure is considered a risk factor for COVID-19. Aim and objectives To characterise the clinical course in hypertensive patients admitted for COVID-19 and to determine if treatment with RAAS inhibitors, age and additional comorbidities may be related to mortality and development of acute respiratory distress syndrome (ARDS). Material and methods A single centre, observational, retrospective study was conducted. Inclusion criteria were: diagnosis of hypertension, hospital admission for COVID-19 between 1 March and 24 March 2020. Demographic, clinical and analytical variables were recorded. Clinical course was evaluated by: development of bilateral pneumonia, ARDS, length of stay and mortality. End of follow-up was 10 October 2020. To evaluate the possible influence of factors on evolution, binary logistic regression was performed using the STATA-IC14 programme. Quantitative dependent variables were transformed into dichotomous variables. Statistical significance was defined as p<0.05. Results 571 patients were analysed, with a median age of 76 years (IQR 66-83) and 59.2% were men. Of these, 69.7% were receiving treatment with RAAS inhibitors, 7.2% smoked and 80.0% had additional comorbidities. At hospital admission, 27.3% presented with hypoxaemia (SatO2<90%), 64.3% lymphopenia (<1000/mm3), 18.8% C reactive protein >20 mg/dL and 11.7% D-dimer >1200 ng/mL. During the hospital stay, 91.9% of patients required oxygen therapy, 76.4% developed bilateral pneumonia, 91.9% required oxygen therapy, 47.5% developed ARDS and 33.6% died. Median hospital stay was 15 days (IQR 9-24). Use of RAAS inhibitors was not linked to changes in mortality or development of ARDS (p>0.05). Risk factors associated with mortality were: additional cardiovascular diseases (OR=2.10;p=0.000) and older age (OR=1.05;p=0.000). Regarding ARDS, we found an association with obesity (OR=1.77;p=0.013), diabetes mellitus (OR=1.84;p=0.001) and age (OR=1.02;p=0.010). Hospital stay >14 days was significantly longer in advanced age (OR=1.02;p=0.022) and if chronic kidney disease was present (OR=1.73, p=0.043). Conclusion and relevance Antihypertensive treatment with RAAS inhibitors did not seem to be linked to the risk of worse evolution of COVID-19. Advanced age and additional cardiovascular disease appeared to be associated with higher mortality in hypertensive patients.
ABSTRACT
Objectives:To analyze the risk of admission for COVID19 infection and outcome of patients treated with bDMARD or tsDMARD from our biologic therapy center, to compare with all patients admitted for COVID-19 infection in our hospital.Methods:Records of the patients from our center admitted for COVID-19 infection between March 8 and May 8, 2020 were analyzed retrospectively. Age, gender, and outcome of all patients admitted for COVID19 infection to our hospital on the same dates were collected. Chi-square, Student’s t and Man-Whitney U tests were used for comparisons when appropriate.Results:1,668 patients with inflammatory diseases treated with bDMARD or tsDMARD were included. Median age 53.0 years (range 17-91), 52.4% women. Diagnoses and DMARD distribution are shown in tables 1 and 2. 19/1668 (1.1%;6.8 patient-years) were admitted for severe COVID19 infection. Mortality ratio: 4/19 (21.1%). Median age of the admitted patients was higher: 61.0y (SD 14.2) vs 53.0y (SD 15.0);p 0.009. Median age of deceased patients was also higher 69.5y (SD 20.3) vs 53.0y (SD 15.0);p: NS. Female gender had a worse prognosis trend: 52.4% of all group, 68.4% of those hospitalized, 75.0% of those who died. Females had a higher median age than men: 55.0y (SD 14.9) vs. 50.0y (SD 14.9);p 0.001.When comparing patients treated with DMARD admitted for COVID19 infection with all patients hospitalized for the same reason (4,601patients), no differences were found neither in age (61.0y [SD 14.2] vs 58.3y [SD 18.1];NS) nor gender (female: 68.4% vs 54.7%;NS). However, DMARD group seemed to have higher mortality: 4/19 (21.1%) vs 551/4601 (12.0%);p: NS, at a younger age: 69.5y (SD 20.3) vs 82.4 (SD 11.4);p: NS.Rheumatoid arthritis patients were admitted more frequently: (9/392 (2.3%) vs 10/1276 (0.8%);p 0.025. And were older: median 62y (SD 13.5) vs 50.0y (SD 14.4);p 0.001.Patients treated with anti-TNF suffered less admissions: 6/1055 (0.6%) vs 13/613 (2.1%);p0.001 and were younger: median 51.0y (SD 15.0) vs 55.0y (SD 14.7);p 0.001. Anti-TNF were less used in patients with rheumatoid arthritis 188/392 (48.0%) vs 867/1276 (67.9%);p0.001.DiseaseN (%)AdmitteddeathsRheumatoid arthritis Spondylarthritis Psoriatic arthritis JIA CTD Vasculitis IBD Psoriasis Others392 (23.5%) 277 (16.6%) 124 (7.4%) 30 (1.8%) 31 (1.9%) 20 (1.2%) 582 (34.9%) 202 (12.1%) 10 (0.6%)9/392 (2.3%) 2/277 (0.7%) 1/124 (0.8%) 0/30 (0.0%) 1/31 (3.2%) 0/20 (0.0%) 4/578 (0.7%) 2/202 (1.0%) 0/10 (0.0%)1 1 0 0 1 0 1 0 0TOTAL1,668 (100%)19/1668 (1.1%)4/19 (21.1%)JIA: Juvenile Idiopathic Arthritis;CTD: Connective Tissue Disease;IBD: Inflammatory Bowel DiseaseTreatmentN (%)AdmitteddeathsAnti-TNF Anti-CD20 Anti-IL6 CTLA4-Ig Anti-IL17 Anti-IL12/23 Anti-integrin JAK inhibitor PDE4 inhibitor Anti-IL231055 (63.2%) 79 (4.7%) 96 (5.8%) 44 (2.6%) 92 (5.5%) 143 (8.6%) 79 (4.7%) 34 (2.0%) 32 (1.9%) 14 (0.8%)6/1055 (0.6%) 3/79 (3.8%) 3/96 (3.1%) 3/44 (6.8%) 2/92 (2,2%) 1/143 (0.7%) 0/79 (0.0%) 1/34 (2.9%) 0/32 (0.0%) 0/14 (0.0%)2 1 0 1 0 0 0 0 0 0TOTAL1,668 (100%)19/1668 (1.1%)4/19 (21.1%)Conclusion:It seems reasonable that patients with inflammatory diseases treated with bDMARD or tsDMARD continue their treatment during the COVID19 epidemic. The different rates of hospitalization based on the diagnosis or DMARD may be due to comorbidity, confounding by indication and other bias. The study is not powerful enough to study these confounders.Disclosure of Interests:Carlos Gonzalez Consultant of: Gilead, Janssen, Novartis, Speakers bureau: Abbvie, Celgene, Gilead, Janssen, Novartis, Pfizer, Roche, Luis Alberto Menchén Viso Grant/research support from: Abbvie, Janssen, MSD, Takeda, Consultant of: Abbvie, Janssen, Takeda, MSD, Medtronic, Tillotts, Pfizer, Dr. Falk Pharma, Speakers bureau: Abbvie, Janssen, Takeda, MSD, General Electric, Tillotts, Pfizer, Ferring, General Electric, Fresenius, Ofelia Baniandrés Rodríguez: None declared, Ana Herranz Alonso: None declared, Carmen Lobo Rodríguez: None declared, Juan Carlos Nieto Speakers bureau: Pfizer, Abbvie, MSD, Novartis, Janssen, Li ly, Nordic Pharma, BMS, Gebro, FAES Farma, Roche, Sanofi, Indalecio Monteagudo Sáez: None declared, Ignacio Marín Jiménez: None declared, Amparo López: None declared, Ana López: None declared, Arantza Ais Larisgoitia: None declared, Esther Chamorro de Vega: None declared, Paloma Morales de los Ríos: None declared, Maria Jesus Lizcano: None declared, Jose Maria Alvaro Gracia: None declared, Sonia García de San José: None declared