Multidisciplinary Management of the Adverse Effects of Apremilast. / Manejo de los efectos adversos de apremilast desde un abordaje multidisciplinar.

We present a series of general and specific recommendations based on pathophysiologic considerations for managing the most common adverse effects of apremilast that lead to treatment discontinuation: diarrhea, nausea, and headache. The recommendations are based on a review of the literature and the experience of a multidisciplinary team of 14 experts including dermatologists, rheumatologists, neurologists, gastroenterologists, pharmacists, and nurses. We propose a series of simple algorithms that include clinical actions and suggestions for pharmacologic treatment. The adverse effects of apremilast can be managed from a multidisciplinary approach. The purpose of optimizing management is to bring clinical benefits to patients.

The influence of patient beliefs and treatment satisfaction on the discontinuation of current first-line antiretroviral regimens.

OBJECTIVES: Large cohort studies have shown a high rate of first-line combination antiretroviral therapy (cART) regimen discontinuation in HIV-infected patients, attributed to characteristics of the cART regimen or toxicity. METHODS: A cohort study of 274 patients receiving a first-line regimen was carried out. Patients' perceptions and beliefs prior to initiation were assessed using an attitude towards medication scale (0-15 points), and their satisfaction during therapy was assessed using an HIV treatment satisfaction questionnaire (HIVTSQ). Treatment discontinuation was defined as any switch in the cART regimen. RESULTS: During 474.8 person-years of follow-up, 63 (23%) patients changed their cART regimen, mainly because of toxicity/intolerance (42; 67%). The overall rate of change was 13.2 per 100 patient-years [95% confidence interval (CI) 11.1-16.4 per 100 patient-years]. An efavirenz (EFV)-based single tablet regimen showed the highest rate of adverse events (27%), but the lowest rate of change (16%; 7.44 per 100 patient-years). Cox regression revealed a decreased hazard of first regimen termination with better initial attitude towards drugs [hazard ratio (HR) 0.76; 95% CI 0.62-0.93; P < 0.01] and higher satisfaction (HR 0.94; 95% CI 0.89-0.99; P = 0.01), and an increased hazard of termination with the presence of adverse events (HR 7.7; 95% CI 2.4-11.6; P < 0.01). One-third of patients (18 of 59; 31%) with mild/moderate adverse events (which were mainly central nervous system symptoms) continued the regimen; these patients, compared with those discontinuing therapy, showed better perception of therapy (mean score 14.4 versus 12.1, respectively; P = 0.05) and greater satisfaction during therapy (mean score 50.6 versus 44.6, respectively; P = 0.04). CONCLUSIONS: Patients' beliefs and satisfaction with therapy influence the durability of the first antiretroviral regimen. These patient-related factors modulate the impact of mild adverse events, and could explain differences in the rate of discontinuation.

[Failure modes and effects analysis in the prescription, validation and dispensing process]. / Análisis modal de fallos y efectos del proceso de prescripción, validación y dispensación de medicamentos.

OBJECTIVE: To apply a failure modes and effects analysis to the prescription, validation and dispensing process for hospitalised patients. METHODS: A work group analysed all of the stages included in the process from prescription to dispensing, identifying the most critical errors and establishing potential failure modes which could produce a mistake. The possible causes, their potential effects, and the existing control systems were analysed to try and stop them from developing. The Hazard Score was calculated, choosing those that were ≥ 8, and a Severity Index = 4 was selected independently of the hazard Score value. Corrective measures and an implementation plan were proposed. RESULTS: A flow diagram that describes the whole process was obtained. A risk analysis was conducted of the chosen critical points, indicating: failure mode, cause, effect, severity, probability, Hazard Score, suggested preventative measure and strategy to achieve so. Failure modes chosen: Prescription on the nurse's form; progress or treatment order (paper); Prescription to incorrect patient; Transcription error by nursing staff and pharmacist; Error preparing the trolley. CONCLUSIONS: By applying a failure modes and effects analysis to the prescription, validation and dispensing process, we have been able to identify critical aspects, the stages in which errors may occur and the causes. It has allowed us to analyse the effects on the safety of the process, and establish measures to prevent or reduce them.