PCSK9 inhibitors revisited: Effectiveness and safety of PCSK9 inhibitors in a real-life Spanish cohort.

INTRODUCTION: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) have emerged as a therapeutic option for patients with hypercholesterolemia who do not attain low-density lipoprotein cholesterol (LDL-C) goals and/or are intolerant to other lipid-lowering drugs. Our aim was to analyze the effectiveness and safety of PCSK9i in routine clinical practice and factors related to poor outcomes. MATERIALS AND METHODS: We conducted an ambispective study in 115 patients who recieved alirocumab or evolocumab, in a tertiary level hospital. From February 2017 to April 2020, patients were recruited and followed up for a median of 20.4 months. The main outcomes were relative reduction in LDL-C, percentage of patients achieving the therapeutic goals established by 2016 ESC/EAS guidelines, incidence of major cardiovascular events (MACEs) and drug-related adverse events (ADRs). RESULTS: The median LDL-C achieved was 57.0 mg/dL (relative reduction of 59.9% from baseline, p< 0.001). After adjusting for confounders, smaller LDL-C reductions were related to female sex, absence of concomitant lipid-lowering therapy and treatment with alirocumab. Overall, 84.6% of the patients achieved the therapeutic goals. During follow-up, 7 MACEs were detected. ADRs, generally considered mild, affected 38.1% of the participants (mainly mialgias and arthralgias) and triggered discontinuations in 8.7% of cases. CONCLUSIONS: PCSK9i are effective and safe, although certain factors may influence their effectiveness. Interestingly, our results suggest that alirocumab and evolocumab may not be therapeutic equivalents, as initially suggested.

Use of the EFQM excellence model to improve hospital pharmacy performance.

BACKGROUND: Quality management systems are widely used to improve the quality and efficiency of healthcare services. However, evidence regarding the value of the European Foundation for Quality Management (EFQM) model in improving the performance of hospital departments is lacking. OBJECTIVE: To describe the value of the EFQM model as a quality framework for improving the performance of a hospital pharmacy department (PD). DESIGN: A case study describing the development of the Enablers' criteria of the model and the results achieved. SETTING: PD in a tertiary-care teaching hospital of the Madrid Public Health Service (Spain). INTERVENTIONS: Four self-assessments were conducted using the questionnaire "Perfil" during the period 2008-2017. A quality improvement plan was developed on the basis of the results of each self-assessment. A balanced scorecard was used to track progress. Improvement in quality management was externally evaluated by the Spanish Management Excellence Club in 2010, 2013, and 2017. MAIN OUTCOME MEASURES: Change in the scores obtained in the external assessments, the quality improvement initiatives implemented for each Enabler's criteria, and the results of key performance indicators. RESULTS: The EFQM was a useful framework for self-assessment and a good system for identifying improvement initiatives. The model progressively improved the services provided for patients, the safety and efficiency of pharmacotherapy, productivity of the PD, and customer and staff satisfaction. The external assessment scores exceeded 300 points in 2010, 400 points in 2013, and 500 points in 2017. Scores for all of the criteria progressively improved, particularly in 'people'. CONCLUSIONS: The EFQM was a practical tool for improvement of PD performance, especially in areas such as strategic planning, people management, and innovation. The main difficulties were the lack of decision-making capacity in relevant areas and benchmarking with other PDs.

Acyclovir and hyponatremia: a case report.

A 61-year-old man attended the emergency department with decreased level of consciousness, repetitive language, and memory loss. Clinical history included type II diabetes and hypertension. Domiciliary treatment included oral metformin 850 mg every 24 hours and oral indapamide 2.5 mg every 24 hours. Laboratory tests disclosed high glycemia (198 mg/dL), increased C-reactive protein (7.4 mg/dL), and normal renal function. Intravenous acyclovir of 800 mg every 8 hours was started on admission due to suspicion of viral encephalitis. Blood analysis on 10th day displayed hyponatremia (123 mmol/L) that was at first explained by the high water intake in the 3 preceding days; therefore, water restriction was decided. Nuclear magnetic resonance on day 14 identified an ictus and treatment with acyclovir was withdrawn. Three days after the withdrawal, plasmatic sodium levels began to increase (128 mmol/L) and returned to normal after 6 days (133 mmol/L). Although hyponatremia is not mentioned in the acyclovir summary of product characteristics, 2 reports in literature suggest that this drug could be a causative agent of hyponatremia. We believe that there is a relationship between acyclovir and hyponatremia. Application of the Karch and Lasagna algorithm to assess the causality of the reaction induced by acyclovir revealed the relationship to be possible.

The impact of medication reconciliation program at admission in an internal medicine department.

BACKGROUND: Medication reconciliation process has proved to be an effective tool to improve the safety of drug use. The objective of this study was to assess the impact of an intervention aimed to decrease unintended discrepancies between patient's usual treatment and medications prescribed on admission to the Department of Internal Medicine. METHODS: A quasi-experimental study was carried out from June 2009 to May 2010, analyzing discrepancies between home medication and drugs prescribed in a tertiary care hospital, before (first phase) and after (second phase) an electronic reconciliation tool was introduced at admission. This tool connected patients' usual medication with the electronic prescription program. The research team was made up of two hospital pharmacists, two nurses and three physicians from the Internal and Preventive Medicine Departments. RESULTS: During the two phases of the study, 162 patients were included with a total of 1,959 medicines reconciled. The incidence of unintended discrepancies decreased from 3.5% to 1.8% after the intervention (p value 0.03). The proportion of patients with at least one unintended discrepancy was 23.7% in the first phase and 14.6% in the second phase (p value 0.20). Omission was the most common unintended discrepancy. Asthmatic patients showed 6 times higher risk of being affected by an unintended discrepancy (OR 6.37, 95%CI 1.6-25.5; p value 0.009). CONCLUSIONS: Implementing a computerized tool integrated into the electronic prescribing program could be very helpful to develop a medication reconciliation process. It is essential to involve all hospital staff in this process.

Comparison of medication error rates and clinical effects in three medication prescription-dispensation systems.

PURPOSE: Medication errors (MEs) are important in terms of their magnitude and severity, and there are numerous systems in place to reduce their occurrence. However, the ideal system has not yet been identified. The authors' institution uses three different medication prescription-dispensation systems which operate simultaneously. ME rates were compared, overall and by phase (prescription, transcription and administration) and their overall and specific clinical impact. DESIGN/METHODOLOGY/APPROACH: The administration of medicinal products was observed directly and compared with medical and nursing prescriptions. Errors and adverse events were classified by a consensus of experts. FINDINGS: In the traditional system the error prevalence rate was 13.59 per cent, (99 per cent CI, 12.15-14.61 per cent), in the single dose system it was 6.43 per cent (99 per cent CI, 5.53-7.32) and in the electronic prescription system it was 8.86 per cent (99 per cent CI, 7.33-10.17). The highest error rates in all phases were found in the traditional system. The phase affected by most errors in all three models was transcription, and the least affected was administration, except for the single dose system, in which prescription was the worst. The effects of errors in the administration phase are greater, although less so than with the automated system. RESEARCH LIMITATIONS/IMPLICATIONS: The dispensation phase was not analyzed. PRACTICAL IMPLICATIONS: A study of errors will enable us to reduce their occurrence if we know the most frequent types and in which phase they are produced, we will be able to prioritise the areas in which to work and select the necessary preventive measures. ORIGINALITY/VALUE: It is possible that automated medication dispensation systems reduce error rates and the severity of their effects.

Medication error prevalence.

PURPOSE: Healthcare risk epidemiology identifies medication error as the commonest cause of adverse effects on patients. Medication error can occur at any phase of the complex medication process so prevalence rates need to be estimated at each drug treatment phase: prescription, transcription and administration along with their clinical repercussions. This paper aims to investigate this issue. DESIGN/METHODOLOGY/APPROACH: Medication errors were recorded on an ad hoc sheet and staff were observed handling medications. Recorded errors were later classified and their clinical repercussions determined by experts. FINDINGS: In total 757 inpatients and 5466 drug prescriptions were studied. The prescription error rate was 4.79 percent (95 percent CI 4.21-5.36). The most frequent error in this phase was failing to observe international prescribing standards. The highest error rate was found in transcription (14.61 percent, 95 percent CI 13.67-15.54). Almost 1900 dose administrations were observed. There was a 9.32 percent error rate (95 percent CI 7.98-10.67). The commonest error in this phase was omission. Most were transcription errors, which were detected before harm wasdone. RESEARCH LIMITATIONS/IMPLICATIONS: The dispensation phase is absent. PRACTICAL IMPLICATIONS: Errors can be reduced if they are understood. Education and training based on the study's findings can reduce medication errors. ORIGINALITY/VALUE: The paper highlights ways to reduce errors in the medication process.

Encuestas de satisfacción al personal facultativo y de enfermería como método de mejora de la calidad de los procesos del servicio de farmacia / Questionnaires on medical and nursing staff satisfaction as a method of improving

Objetivo: Describir los resultados de una encuesta de satisfacción dirigida al personal facultativo y de enfermería como método de mejora de la calidad de los procesos, de acuerdo con la norma ISO 9001:2000. Método: Estudio transversal mediante cuestionario autoadministrado. Se calculó un tamaño muestral de 405 para enfermería y 337 para los facultativos, asumiendo un porcentaje general de satisfacción del 80%, con una precisión del 3,5% y un riesgo alfa de 0,05. Resultados: La tasa de respuesta fue del 46,4% entre el personal de enfermería y del 24,3% entre los facultativos. La satisfacción general fue favorable para el 80,3% de enfermería y para el 96,3% de los facultativos. El ítem mejor valorado por ambos grupos fue la amabilidad del farmacéutico. Lo peor valorado por enfermería fue el cumplimiento del horario pactado para dispensar los pedidos y por los facultativos, el horario de dispensación de la farmacia. Conclusiones: La satisfacción percibida por enfermería y facultativos es una de las fuentes de información útil para establecer acciones de mejora dentro de la acreditación según la norma ISO 9001:2000

Objective: To report the results of a survey directed at medical and nursing staff as a method of improving the quality of procedures, in accordance with standard ISO 9001:2000. Method: Cross-sectional study using a self-administered questionnaire. A sample size of 405 was calculated as 405, for nurses and 337 for medical staff, assuming an overall percentage of satisfaction of 80%, with a precision of 3.5% and an alpha risk of 0.05. Results: The response rate was 46.4% for nursing staff and 24.3% for medical personnel. The overall satisfaction was favourable in 80.3% of nurses and 96.3% of doctors. The best valued item by both groups was the friendliness of the pharmacist. The worst valued by nursing staff, was the compliance to the agreed opening times for dispensing orders, and for doctors, the pharmacy opening times. Conclusions: The perceived satisfaction by nursing and medical staff is one of the most useful sources of information for establi-shing improvement processes for accreditation in accordance with ISO 9001:2000

[Not Available]. / Encuestas de satisfacción al personal facultativo y de enfermería como método de mejora de la calidad de los procesos del servicio de farmacia.

OBJECTIVE: To report the results of a survey directed at medical and nursing staff as a method of improving the quality of procedures, in accordance with standard ISO 9001:2000. METHOD: Cross-sectional study using a self-administered questionnaire. A sample size of 405 was calculated as 405, for nurses and 337 for medical staff, assuming an overall percentage of satisfaction of 80%, with a precision of 3.5% and an alpha risk of 0.05. RESULTS: The response rate was 46.4% for nursing staff and 24.3% for medical personnel. The overall satisfaction was favourable in 80.3% of nurses and 96.3% of doctors. The best valued item by both groups was the friendliness of the pharmacist. The worst valued by nursing staff, was the compliance to the agreed opening times for dispensing orders, and for doctors, the pharmacy opening times. CONCLUSIONS: The perceived satisfaction by nursing and medical staff is one of the most useful sources of information for establishing improvement processes for accreditation in accordance with ISO 9001:2000.