Effectiveness, Safety, and Adherence to Treatment of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Real Practice.

PURPOSE: To evaluate the effectiveness, adverse reactions, and adherence to treatment of hypolipidemic inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9is) in a context of real clinical practice. METHODS: We present an observational, retrospective, descriptive, multicenter study of patients with hypercholesterolemia who began treatment with PCSK9is between January 2017 and December 2019, with a minimum treatment period of 3 months. The main variable we recorded was the frequency of cardiovascular events (cardiovascular death, myocardial infarction, stroke, coronary revascularization, and hospitalization for unstable angina) in patients treated with PCSK9is. We recorded patient demographic characteristics and cardiovascular risk factors at onset of treatment as well as LDL-C levels and their reductions at 3, 6, 12, and 24 months. We calculated adherence to treatment and recorded the adverse reactions during treatment. FINDINGS: A total of 154 patients were studied, 64 (41.6%) of whom were treated with alirocumab and 90 (58.4%) with evolocumab. The initial dose of alirocumab was 75 mg every 14 days in 48 patients (75%) and 150 mg eery 14 days in 16 (25%). All patients who in the evolocumab group received a dose of 140 mg every 14 days. The mean (SD) basal LDL-C level was 159.6 (50.1) mg/dL, the level at 3 months was 87.9 (49.9) mg/dL (mean [SD] decrease, 44.5% [28.2%]), the level at 6 months was 86.7 (49.2) mg/dL (mean [SD] decrease, 46.3% [25.6%]), and the level at 12 months was 80.5 (41.4) (mean [SD] decrease, 48.9% [23.0%]). These values were maintained at 24 months (mean [SD], 80.3 [41.8] mg/dL; mean [SD] decrease, 47.9% [27.8%]). The percentage decrease of LDL-C for both drugs was approximately 50%, which was maintained until 24 months after treatment. Six patients (3.9%) presented with some cardiovascular event: acute myocardial infarction (2 [1.3%]), stroke (1 [0.65%]), coronary revascularization (1 [0.65%]), and hospitalization for unstable angina (2 [1.3%]). We did not see any adverse reactions related to PCSK9i treatment in 76.5% of patients. In the first 6 months, adherence to treatment with PCSK9is, measured as the possession ratio, was a mean (SD) of 99.4% (3.9%). In the rest of the study period (6-24 months), the mean (SD) adherence to treatment was 99.2% (4.7%). IMPLICATIONS: The frequency of cardiovascular events in patients treated with PCSK9is was low and occurred despite adequate adherence to treatment (100% possession ratio) with PCSK9is and concomitant treatment with other hypolipidemics. The effectiveness of PCSK9is is similar to that referred to in other published studies with PCSK9is, and this was maintained in the long term (24 months) with few adverse events, all of which were mild.

Real-world prevalence and consequences of potential drug-drug interactions in the first-wave COVID-19 treatments.

WHAT IS KNOWN AND OBJECTIVE: Initial treatment recommendations of COVID-19 were based on the use of antimicrobial drugs and immunomodulators. Although information on drug interactions was available for other pathologies, there was little evidence in the treatment of COVID-19. The objective of this study was to analyse the potential drug-drug interactions (pDDIs) derived from the medication used in COVID-19 patients in the first pandemic wave and to evaluate the real consequences of such interactions in clinical practice. METHODS: Cohort, retrospective and single-centre study carried out in a third-level hospital. Adult patients, admitted with suspected COVID-19, that received at least one dose of hydroxychloroquine, lopinavir/ritonavir, interferon beta 1-b or tocilizumab and with any pDDIs according to "Liverpool Drug Interaction Group" between March and May 2020 were included. The possible consequences of pDDIs at the QTc interval level or any other adverse event according to the patient's medical record were analysed. A descriptive analysis was carried out to assess possible factors that may affect the QTc interval prolongation. RESULTS AND DISCUSSION: Two hundred and eighteen (62.3%) patients of a total of 350 patients admitted with COVID-19 had at least one pDDI. There were 598 pDDIs. Thirty-eight pDDIs (6.3%) were categorized as not recommended or contraindicated. The mean value difference between baseline and pDDI posterior ECG was 412.3 ms ± 25.8 ms vs. 426.3 ms ± 26.7 ms; p < 0.001. Seven patients (5.7%) had a clinically significant alteration of QTc. A total of 44 non-cardiological events (7.3%) with a possible connection to a pDDI were detected. WHAT IS NEW AND CONCLUSION: The number of pDDIs in patients admitted for COVID-19 in the first pandemic wave was remarkably high. However, clinical consequences occurred in a low percentage of patients. Interactions involving medications that would be contraindicated for concomitant administration are rare. Knowledge of these pDDIs and their consequences could help to establish appropriate therapeutic strategies in patients with COVID-19 or other diseases with these treatments.

Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy.

Hospital Pharmacy Service (HPS) in Spain have been impacted by the health  crisis caused by the COVID-19 pandemic. Thus, the outbreak has forced HPSs to adapt their outpatient consultation services to Telepharmacy to optimize clinical  outcomes and reduce the risk of contagion. The purpose of this article is to  describe and analyze the experience of HPSs with outpatient Telepharmacy  during the COVID-19 pandemic and expose the lessons learned. Measures have  been adopted in on-site outpatient pharmacy clinics to prevent exposure of  patients and professionals to the virus. These measures are based on national  and international recommendations on social distancing and hygiene. With  regard to remote outpatient pharmacy services, teleconsultation with drug  dispensing has been promoted based on five basic procedures, each with its  advantages and limitations: home drug delivery from HPSs, with the advantage  of universal access and the limitation of entailing a substantial investment in  resources; HPS coordination with primary care pharmacists, which requires no  investments but with limited access to some geographic areas; HPS coordination with community pharmacists based on a large network of pharmacies, which  requires the patient to go to the pharmacy, without confidentiality being  guaranteed for any patient; geolocation and hospital-based medication  dispensing, which provides universal access and direct traceability, but entails  investment in human resources; and HPS coordination with associations of  patients, which does not entail any additional cost but limits the information  available on the diseases of society members. Three main lessons have been learned during the pandemic: the satisfactory capacity of HPS to provide outpatient pharmacy consultation services in the setting of a public health crisis; the usefulness of Telepharmacy for the clinical follow-up, healthcare coordination, outpatient counseling, and informed dispensing and delivery of  medication (with a high level of satisfaction among patients); and the need to  foster Telepharmacy as a complementary tool through a mixed model of  outpatient pharmacy consultation service that incorporates the advantages of  each procedure and adapts to the individual needs of each patient in a context of humanized healthcare.

Los servicios de farmacia hospitalaria (SFH) en España se han visto afectados  por la crisis sanitaria provocada por SARS-CoV-2 y han tenido que adoptar sus  procedimientos de atención farmacéutica (AF) al paciente externo (PE) mediante estrategias de Telefarmacia, con los objetivos de maximizar los resultados en  salud y reducir el riesgo de contagio. El objetivo de ese artículo es describir y  analizar los procedimientos AFPE durante la pandemia SARS-CoV-2 y comunicar  las lecciones aprendidas en los SFH. En relación con las consultas externas de AF presenciales, se han adoptado medidas para minimizar el contagio viral de  pacientes y profesionales, siguiendo las recomendaciones nacionales e  internacionales de referencia de distanciamiento temporal, espacial y  recomendaciones higiénicas. En cuanto a las consultas externas de AF no  presenciales, se han potenciado las teleconsultas con dispensación del  tratamiento en base a cinco procedimientos básicos, cada uno de ellos con sus  ventajas y limitaciones: dispensación domiciliaria desde SFH que presenta las  ventajas de la universalidad de acceso, pero requiere una elevada inversión en  recursos; coordinación del SHF con farmacéuticos de atención primaria, que  conlleva una nula inversión en recursos, pero limita el acceso a determinadas zonas geográficas; coordinación del SFH con farmacéuticos comunitarios, que  utiliza una amplia red de oficinas de farmacia, pero exige el desplazamiento del  paciente sin garantías de confidencialidad para todos los casos; geolocalización y dispensación hospitalaria, que permite un acceso universal y trazabilidad directa, pero requiere un incremento en recursos humanos; y coordinación del SFH con  asociaciones de pacientes, que no requiere inversión económica, pero limita el  acceso a las patologías de los asociados. Destacamos finalmente tres lecciones  aprendidas: la capacidad de AFPE de SFH españoles ante una crisis sanitaria; la  utilidad de la Telefarmacia para el seguimiento clínico, la coordinación  asistencial, información al PE, dispensación y entrega informada (con elevada  satisfacción de los pacientes); y la necesidad de potenciar la Telefarmacia como herramienta complementaria, en un modelo mixto de AFPE que incorpore las  ventajas de cada uno de los procedimientos adaptándose a las necesidades individuales de los pacientes en un entorno de humanización de la asistencia  sanitaria.

Atención farmacéutica al paciente externo durante la pandemia COVID-19. Telefarmacia / Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy

Los servicios de farmacia hospitalaria (SFH) en España se han visto afectados por la crisis sanitaria provocada por SARS-CoV-2 y han tenido que adoptar sus procedimientos de atención farmacéutica (AF) al paciente externo (PE) mediante estrategias de Telefarmacia, con los objetivos de maximizar los resultados en salud y reducir el riesgo de contagio. El objetivo de ese artículo es describir y analizar los procedimientos AFPE durante la pandemia SARS-CoV-2 y comunicar las lecciones aprendidas en los SFH. En relación con las consultas externas de AF presenciales, se han adoptado medidas para minimizar el contagio viral de pacientes y profesionales, siguiendo las recomendaciones nacionales e internacionales de referencia de distanciamiento temporal, espacial y recomendaciones higiénicas. En cuanto a las consultas externas de AF no presenciales, se han potenciado las teleconsultas con dispensación del tratamiento en base a cinco procedimientos básicos, cada uno de ellos con sus ventajas y limitaciones: dispensación domiciliaria desde SFH que presenta las ventajas de la universalidad de acceso, pero requiere una elevada inversión en recursos; coordinación del SHF con farmacéuticos de atención primaria, que con-lleva una nula inversión en recursos, pero limita el acceso a determinadas zonas geográficas; coordinación del SFH con farmacéuticos comunitarios, que utiliza una amplia red de oficinas de farmacia, pero exige el desplazamiento del paciente sin garantías de confidencialidad para todos los casos; geolocalización y dispensación hospitalaria, que permite un acceso universal y trazabilidad directa, pero requiere un incremento en recursos humanos; y coordinación del SFH con asociaciones de pacientes, que no requiere inversión económica, pero limita el acceso a las patologías de los asociados. Destacamos finalmente tres lecciones aprendidas: la capacidad de AFPE de SFH españoles ante una crisis sanitaria; la utilidad de la Telefarmacia para el seguimiento clínico, la coordinación asistencial, información al PE, dispensación y entrega informada (con elevada satisfacción de los pacientes); y la necesidad de potenciar la Telefarmacia como herramienta complementaria, en un modelo mixto de AFPE que incorpore las ventajas de cada uno de los procedimientos adaptándose a las necesidades individuales de los pacientes en un entorno de humanización de la asistencia sanitaria

Hospital Pharmacy Service (HPS) in Spain have been impacted by the health crisis caused by the COVID-19 pandemic. Thus, the outbreak has forced HPSs to adapt their outpatient consultation services to Telepharmacyto optimize clinical outcomesand reduce the risk of contagion. The purpose of this article is to describe and analyze the experience of HPSs with out-patient Telepharmacy during the COVID-19 pandemic and expose the les-sons learned. Measures have been adopted in on-site outpatient pharmacy clinics to prevent exposure of patients and professionals to the virus. These measures are based on national and international recommendations on social distancing and hygiene. With regard to remote outpatient pharmacy services, teleconsultation with drug dispensing has been promoted based on five basic procedures, each with its advantages and limitations: home drug delivery from HPSs, with the advantage of universal access and the limitation of entailing a substantial investment in resources; HPS coordination with primary care pharmacists, which requires no investments but with limited access to some geographic areas; HPS coordination with community pharmacists based on a large network of pharmacies, which requires the patient to go to the pharmacy, without confidentiality being guaranteed for any patient; geolocation and hospital-based medication dispensing, which provides universal access and direct traceability, but entails investment in human resources; and HPS coordination with associations of patients, which does not entail any additional cost but limits the information available on the diseases of society members. Three main lessons have been learned during the pandemic: the satisfactory capacity of HPS to provide outpatient pharmacy consultation services in the setting of a public health crisis; the usefulness of Telepharmacy for the clinical follow-up, healthcare coordination, outpatient counseling, and informed dispensing and delivery of medication (with a high level of satisfaction among patients); and the need to foster Telepharmacy as a complementary tool through a mixed model of outpatient pharmacy consultation service that incorporates the advantages of each procedure and adapts to the individual needs of each patient in a context of humanized healthcare