Revisión de medicamentos sin receta con aspartamo: Indicación Farmacéutica segura en fenilcetonuria / Review of non-prescription medicines with aspartame: safe pharmaceutical indication in phenylketonuria

Introducción: La fenilcetonuria es el trastorno hereditario más frecuente del metabolismo de los aminoácidos y su abordaje suele centrarse en die-tas restringidas en fenilalanina, un aminoácido presente en el edulcorante aspartamo habitualmente usado como excipiente en tecnología farmacéutica. Objetivo: El objetivo principal es la revisión de los medicamentos sin receta comercializados en España hasta marzo de 2023 y que contienen aspartamo en su composición. Método: Se realizó una revisión en la base de datos BOT plus de todos los medicamentos comercializados en España que contienen aspartamo. Se seleccionaron solo los MSR. Se consultaron las fichas técnicas en el Centro de información online de medicamentos de la AEMPS (CIMA), y los datos obtenidos se registraron en una tabla. Resultados: Se obtuvieron 570 medicamentos; 58 eran MSR. Cuando exista petición de MSR con aspartamo en pacientes con fenilcetonuria, en el SIF, tras su evaluación, en el 100% de los casos, el farmacéutico aplicando el Servicio de Indicación Farmacéutica podría indicar un MSR alternativo, con el mismo principio activo pero sin aspartamo como excipiente. Conclusiones: La actuación del farmacéutico comunitario para aplicar el SIF es muy importante en pacientes con fenilcetonuria. Existen medicamentos que no requieren prescripción y se pueden indicar en estos pacientes. El farmacéutico debe tener a su disposición las herramientas necesarias que le faciliten el SIF con este tipo de enfermos. (AU)

Introduction: Phenylketonuria is the most common inherited disorder of amino acid metabolism and its management usually focuses on diets restricted in phenylalanine, an amino acid present in the sweet-ener aspartame commonly used as an excipient in pharmaceutical technology. Objective: The main objective is the review of non-prescription medicines marketed in Spain until March 2023 and that contain aspartame in their composition.Methods: A review of all medicines marketed in Spain containing aspartame was carried out in the BOT plus database. Only MSRs were selected. The data sheets were consulted at the AEMPS online medicines information centre (CIMA), and the data obtained were recorded in a table.Results: 570 medicines were obtained; 58 were MSRs. When there is a request for MSRs with aspartame in patients with phenylketonuria, in the SIF, after evaluation, in 100% of the cases, the pharmacist applying the Pharmaceutical Indication Service could indicate an alternative MSR, with the same active ingredient but without aspartame as an excipient.Conclusions: The action of the community phar-macist to apply the SIF is very important in patients with phenylketonuria. There are medicines that do not require a prescription and can be prescribed for these patients. Pharmacists should have the necessary tools at their disposal to facilitate the SIF with this type of patient. (AU)

Procedural pain in patients with cancer: a Delphi expert management consensus.

OBJECTIVES: Diagnosis, treatment and care of cancer often involve procedures that may be distressing and potentially painful for patients. The PROCEDIO Study aimed to generate expert-based recommendations on the management of moderate to severe procedural pain in inpatients and outpatients with cancer. METHODS: Using a two-round Delphi method, experts from pain and palliative care units, medical and radiation oncology and haematology departments expressed their agreement on 24 statements using a 9-point Likert scale, which were classified as appropriate (median 7-9), uncertain (4-6) or inappropriate (1-3). Consensus was achieved if at least two-thirds of the panel scored within the range containing the median. RESULTS: With an overall agreement on the current definition of procedural pain, participants suggested a wider description based on evidence and their clinical experience. A strong consensus was achieved regarding the need for a comprehensive pre-procedural pain assessment and experts emphasised that healthcare professionals involved in procedural pain management should be adequately trained. Most panellists (98.2%) agreed that pharmacological treatment should be chosen considering the duration of the procedure. Transmucosal fentanyl (96.5%) and morphine (71.7%) were recommended as the most appropriate drugs. Oral and nasal transmucosal fentanyl were agreed as the most suitable for both outpatients and inpatients, while consensus was reached for intravenous and subcutaneous morphine for inpatients. CONCLUSIONS: These results provide updated expert-based recommendations on the definition, prevention and treatment of moderate to severe procedural pain, which could inform specialists involved in pain management of patients with cancer.

Síndrome post cuidados intensivos en COVID-19. Estudio piloto unicéntrico / Postintensive care syndrome in COVID-19. Unicentric pilot study

Introduction: Postintensive care syndrome (PICS) is the physical, cognitive or psychiatric deterioration that appears after a critical illness and persists beyond hospital admission. The objective of this study was to describe the prevalence of PICS in the patients with coronavirus disease 2019 (COVID-19) admitted to the intensive care unit of the Consorcio Hospital General Universitario de Valencia.PatientsThey benefited from a standardized assessment, addressing health-related quality of life (EuroQol-5D-3L), a physical status (6 MWT, «test up and go» and hand dynamometer), a nutritional assessment (MUST and the Global Subjective Assessment), cognitive impairment (MoCA), mental health disorders (HADS and Davidson Trauma Scale) and pain (visual analogue scale and DN4).ResultsFrom March to June 2020, 59 patients with SARS-CoV-2 were admitted to our ICU. 29 of these were recruited for the study. The stay in the ICU and the mechanical ventilation time were long (24 days [IQR 12–36], and 18 days [IQR 7–31] respectively). The SOFA upon admission to the ICU was high (3 [IQR 3–5]). Tracheostomy was performed in 52% and pronation in 93%. 90% had some abnormal test. 20% had post-traumatic stress syndrome.ConclusionsWe found that 9 out of 10 survivors of SARS-CoV-2 admitted had at least one PICS alteration at 4–6 weeks from discharge from the Hospital. Six out of 19 patients presented with two or more affected evaluated areas. (AU)

Antecedentes y objetivo: El síndrome post cuidados intensivos (SPCI) es el deterioro físico, cognitivo o psiquiátrico que aparece después de una enfermedad crítica y persiste tras el ingreso hospitalario. El objetivo es evaluar la prevalencia de SPCI en los pacientes con enfermedad por coronavirus 2019 (COVID-19) ingresados en la unidad de cuidados críticos (UCI) del Consorcio Hospital General Universitario de Valencia.PacientesSe evaluó la calidad de vida subjetiva (EuroQol-5D-3L), el estado funcional (test de marcha de 6 min, «levanta y anda» y dinamómetro de mano); nutricional (Malnutrition Universal Screening Tool [MUST] y Valoración subjetiva global [VSG]); montreal cognitive assessment (MoCA); mental (escala de ansiedad y depresión hospitalaria [HADS] y escala de Trauma de Davidson) y de dolor (escala visual analógica y detección de dolor neuropático-DN4).ResultadosDel 1 de marzo al 30 de junio del 2020 ingresaron en UCI 59 pacientes por SARS-CoV-2. Contactamos con los 29 supervivientes a las cuatro a seis semanas del alta hospitalaria. La estancia en UCI (24 días [IQR 12-36]) y el tiempo de ventilación mecánica (18 días [IQR 7-31]) fueron prolongados. El Sequential Organ Failure Assessment (SOFA) al ingreso en UCI fue elevado (3 [IQR 3-5]). Se realizó traqueostomía en el 52% y pronación al 93%. En cuanto al SPCI, el 90% tenía algún test alterado. Presentaron dos o más test alterados seis de cada 10. Un 20% presentó el test para detección del trastorno de estrés postraumático (TEPT) patológico.ConclusionesEncontramos que nueve de cada 10 supervivientes de una neumonía por SARS-CoV-2 ingresados en UCI tenían al menos una alteración de SPCI a las cuatro a seis semanas del alta hospitalaria. Los problemas de SPCI concurrentes (dos o más) estuvieron presentes en más de seis de cada 10. Seis de los pacientes presentaron TEPT. (AU)

Postintensive care syndrome in COVID-19. Unicentric pilot study. Calm does not come after the storm.

Introduction: Postintensive care syndrome (PICS) is the physical, cognitive or psychiatric deterioration that appears after a critical illness and persists beyond hospital admission. The objective of this study was to describe the prevalence of PICS in the patients with coronavirus disease 2019 (COVID-19) admitted to the intensive care unit of the Consorcio Hospital General Universitario de Valencia. Patients: They benefited from a standardized assessment, addressing health-related quality of life (EuroQol-5D-3L), a physical status (6 MWT, "test up and go" and hand dynamometer), a nutritional assessment (MUST and the Global Subjective Assessment), cognitive impairment (MoCA), mental health disorders (HADS and Davidson Trauma Scale) and pain (visual analogue scale and DN4). Results: From March to June 2020, 59 patients with SARS-CoV-2 were admitted to our ICU. 29 of these were recruited for the study. The stay in the ICU and the mechanical ventilation time were long (24 days [IQR 12-36], and 18 days [IQR 7-31] respectively). The SOFA upon admission to the ICU was high (3 [IQR 3-5]). Tracheostomy was performed in 52% and pronation in 93%. 90% had some abnormal test. 20% had post-traumatic stress syndrome. Conclusions: We found that 9 out of 10 survivors of SARS-CoV-2 admitted had at least one PICS alteration at 4-6 weeks from discharge from the Hospital. Six out of 19 patients presented with two or more affected evaluated areas.

Antecedentes y objetivo: El síndrome post cuidados intensivos (SPCI) es el deterioro físico, cognitivo o psiquiátrico que aparece después de una enfermedad crítica y persiste tras el ingreso hospitalario. El objetivo es evaluar la prevalencia de SPCI en los pacientes con enfermedad por coronavirus 2019 (COVID-19) ingresados en la unidad de cuidados críticos (UCI) del Consorcio Hospital General Universitario de Valencia. Pacientes: Se evaluó la calidad de vida subjetiva (EuroQol-5D-3L), el estado funcional (test de marcha de 6 min, «levanta y anda¼ y dinamómetro de mano); nutricional (Malnutrition Universal Screening Tool [MUST] y Valoración subjetiva global [VSG]); montreal cognitive assessment (MoCA); mental (escala de ansiedad y depresión hospitalaria [HADS] y escala de Trauma de Davidson) y de dolor (escala visual analógica y detección de dolor neuropático-DN4). Resultados: Del 1 de marzo al 30 de junio del 2020 ingresaron en UCI 59 pacientes por SARS-CoV-2. Contactamos con los 29 supervivientes a las cuatro a seis semanas del alta hospitalaria. La estancia en UCI (24 días [IQR 12−36]) y el tiempo de ventilación mecánica (18 días [IQR 7−31]) fueron prolongados. El Sequential Organ Failure Assessment (SOFA) al ingreso en UCI fue elevado (3 [IQR 3−5]). Se realizó traqueostomía en el 52% y pronación al 93%. En cuanto al SPCI, el 90% tenía algún test alterado. Presentaron dos o más test alterados seis de cada 10. Un 20% presentó el test para detección del trastorno de estrés postraumático (TEPT) patológico. Conclusiones: Encontramos que nueve de cada 10 supervivientes de una neumonía por SARS-CoV-2 ingresados en UCI tenían al menos una alteración de SPCI a las cuatro a seis semanas del alta hospitalaria. Los problemas de SPCI concurrentes (dos o más) estuvieron presentes en más de seis de cada 10. Seis de los pacientes presentaron TEPT.

Postintensive care syndrome in COVID-19. Unicentric pilot study. / Síndrome post cuidados intensivos en COVID-19. Estudio piloto unicéntrico.

INTRODUCTION: Postintensive care syndrome (PICS) is the physical, cognitive or psychiatric deterioration that appears after a critical illness and persists beyond hospital admission. The objective of this study was to describe the prevalence of PICS in the patients with coronavirus disease 2019 (COVID-19) admitted to the intensive care unit of the Consorcio Hospital General Universitario de Valencia. PATIENTS: They benefited from a standardized assessment, addressing health-related quality of life (EuroQol-5D-3L), a physical status (6 MWT, «test up and go¼ and hand dynamometer), a nutritional assessment (MUST and the Global Subjective Assessment), cognitive impairment (MoCA), mental health disorders (HADS and Davidson Trauma Scale) and pain (visual analogue scale and DN4). RESULTS: From March to June 2020, 59 patients with SARS-CoV-2 were admitted to our ICU. 29 of these were recruited for the study. The stay in the ICU and the mechanical ventilation time were long (24 days [IQR 12-36], and 18 days [IQR 7-31] respectively). The SOFA upon admission to the ICU was high (3 [IQR 3-5]). Tracheostomy was performed in 52% and pronation in 93%. 90% had some abnormal test. 20% had post-traumatic stress syndrome. CONCLUSIONS: We found that 9 out of 10 survivors of SARS-CoV-2 admitted had at least one PICS alteration at 4-6 weeks from discharge from the Hospital. Six out of 19 patients presented with two or more affected evaluated areas.

Breakthrough cancer pain treatment in Spain: physicians' perception of current opioids utilization and prescription.

Objectives: Multiple reasons for suboptimal treatment of breakthrough cancer pain (BTcP) have been reported in the literature. We aimed to ascertain the perception of physicians on the potential inappropriate use and prescription of rapid-onset opioids (ROOs) for breakthrough cancer pain (BTcP) and the causes thereof.Methods: Observational study based on an online survey addressed to doctors from different specialties (radiation oncology, medical oncology, anesthesia, palliative care and general practitioners) with experience in the management of BTcP in the Spanish public health setting.Results: A total of 114 eligible specialists mainly from radiation oncology (37.7%), medical oncology (24.6%) and pain units (18.4%) participated in the study. Most agreed on important aspects of BTcP management, such as their preference for ROOs or the need for early follow-up after treatment initiation. However, their answers revealed a lack of standardization of BTcP diagnosis. Half of respondents believed that their BTcP patients might misuse ROOs. Physicians polled believed that lack of training in pain management (71.9%) and inadequate BTcP diagnosis and evaluation (66.7%) were the greatest obstacles for prescribing opioids. Specialists also thought that they do not provide the necessary information to patients (51.8%) and caregivers (57.9%) to guarantee the correct use of these drugs.Conclusions: These results are of utmost importance as they highlight the need to increase physicians' awareness of BTcP and its management and the need to improve communication with patients and their caregivers. Our findings also indicate the need for future research on the possible misuse of opioids in BTcP patients and its causes.

Cultural adaptation and validation of the painDETECT scale into Spanish.

OBJECTIVE: The aim of this study was to culturally adapt into Spanish and validate the painDETECT questionnaire, a brief self-administered instrument designed to screen the presence of a neuropathic pain component in usual clinical practice. METHODS: The original English painDETECT questionnaire was culturally adapted into Spanish (Spain) by 2 independent translators under supervision of an expert panel. The LANNS, and a pain visual analog scale were administered along with the painDETECT questionnaire to a sample of 252 patients with neuropathic, nociceptive, or mixed pain for at least 3 months. Patients were classified by experienced specialists under normal conditions of clinical practice. A retest measure after 24 to 48 hours was also carried out. Reliability, construct validity, convergent validity, criterion, and discriminant validity were assessed. RESULTS: An effective sample of 221 patients with chronic pain was recruited, 32% diagnosed of neuropathic origin, 32% of nociceptive, and remaining 36% presented mixed pain. The average age was 57.8 years (SD=14.2) and 59% were women. Cronbach alpha attained a value of 0.86, and the intraclass correlation coefficient with the retest was 0.93. The factor structure was coherent with the one informed for the original instrument. Pearson correlation with the LANSS scale was 0.88. Area under the receiver operating characteristic curve was 0.88 when comparing neuropathic and nociceptive groups. Using the suggested cutoff value for pain presence of 19 points or higher, the following discriminant values are obtained: sensitivity=75%, specificity=84%, Youden Index=0.595, positive predictive value=92%, and negative predictive value=60%. The absence cutoff value of 12 points or bellow raised the following values: sensitivity=93%, specificity=68%, Youden Index=0.61, positive predictive value=87%, and negative predictive value=80%. When mixed pain patients are included in the group with a neuropathic component, discriminant values are slightly reduced, as expected. CONCLUSIONS: The culturally adapted version of the painDETECT presents good psychometric properties and shows to be a valid patient-reported outcome for measuring the presence of a neuropathic component in patients with chronic pain.

The safety of magnetic resonance imaging in patients with programmable implanted intrathecal drug delivery systems: a 3-year prospective study.

BACKGROUND: It is common clinical practice to perform magnetic resonance imaging (MRI) in patients with indwelling programmable intrathecal drug delivery (IDD) systems, although the safety of the procedure has never been documented. We performed a single-center, 3-year, prospective evaluation in patients with a programmable implanted IDD to assess patient discomfort, IDD technical failures, and adverse effects during and after exposure to MRI. METHODS: Forty-three consecutive patients with an implanted programmable IDD system (SynchroMed® EL Implantable Infusion Pump, Model 8626L-18, and SynchroMed® II Model 8637-20, 8637-40; Medtronic, Inc., Minneapolis, MN) requiring a scheduled MRI evaluation were studied during a 3-year period. All MRI scans were performed with a 1.5-tesla clinical use magnet and a specific absorption rate of no more than 0.9 W/kg. Radiograph control was used to confirm postexposure pump rotor movement and detect system dislocations. IDD system failures, patient satisfaction, and discomfort were recorded. RESULTS: None of the patients experienced signs of drug overinfusion that could lead to hemodynamic, respiratory, or neurologic alterations. Radiologic evaluation after MRI revealed no spatial displacements of the intrathecal catheter tip or body pump, and programmer telemetry confirmed the infusion recovery. Patients' satisfaction after the procedure was high. CONCLUSION: Performing an MRI scan with the proposed protocol in patients with an implanted Medtronic programmable IDD system resulted in virtually no technical or medical complications.

A double-blind, controlled, randomized trial to evaluate the efficacy of botulinum toxin for the treatment of lumbar myofascial pain in humans.

BACKGROUND: Among all the causes of chronic low back pain, myofascial pain syndrome of the spinal stabilizer muscles is one of the most frequent, yet underconsidered sources of pain. The purpose of this prospective, randomized, double-blind, controlled trial was to evaluate the efficacy of type-A botulinum toxin (BTX-A) in relieving myofascial pain in patients experiencing mechanical low back pain due to bilateral myofascial pain syndrome involving the iliopsoas and/or the quadratus lumborum muscles. METHODS: Each of the 27 enrolled patients received a bilateral, fluoroscopically guided injection in the affected muscle(s) to randomly deliver BTX-A in one side of the low back and a control drug (randomly constituted by NaCl 0.9% or bupivacaine 0.25%) in the opposite side. To evaluate the effects of treatment on daily life activities and psychologic status, 5 different questionnaires were administered (Hospital Anxiety and Depression scale [HAD-A and HAD-D], Lattinen, Oswestry, and Spielberger State-Trait Anxiety Index). RESULTS: BTX-A injection did not significantly reduce visual analog scale scores more than treatment with NaCl or bupivacaine in the contralateral side; furthermore, the treatments administered did not result in a significant improvement of patients' daily life activities or psychologic status. Although a trend toward a decrease in postintervention visual analog scale scores could be recognized in all low back sides, this trend was significant only in the sides treated with BTX-A. CONCLUSIONS: BTX-A seems to provide significant postintervention pain relief. However, considering its high cost and the small differences compared with control treatments, its use should be reserved only for patients with pain refractory to other invasive treatments.

Can an intrathecal, catheter-tip-associated inflammatory mass reoccur?

OBJECTIVES: Intrathecal granuloma associated to the tip of catheters implanted in patients receiving long-term spinal infusion to alleviate chronic pain is a rare but potentially catastrophic complication. Its formation seems to be related to the intrathecal administration of opioid drugs, although not all opioids induce granuloma formation with the same frequency. METHODS: In this clinical report, we describe an intrathecal granuloma that reoccur twice in the same patient after its surgical removal. RESULTS AND DISCUSSION: This case report highlights the incomplete knowledge about the mechanism of granuloma formation and discuss the alternatives in the management of catheter-tip granulomas. This is the first case report of a patient in whom an intrathecal granuloma reoccurred twice after initial surgical removal. We also present and discuss a potential management strategy to avoid further surgery and resume intrathecal therapy early.

Epidural Neurostimulation of Posterior Funiculi for the Treatment of Buerger's Disease.

Background. Buerger disease is a nonatherosclerotic, segmental, occlusive and recurrent inflammatory vascular disorder that affects small and medium-sized arteries and veins of the upper and lower extremities. Case reports. We report two cases of Buerger disease. Medical History. Smoking habit. No autoimmune diseases. No diabetes mellitus. Intermittent vascular claudication at 100-150 m. Several hospital admissions for amputations. Prior Medical Treatment. Antiplatelet agents, vasodilators, nonsteroidal anti-inflammatory drugs, third-step analgesics, fibrinolytic treatment and lumbar sympathectomies. Following all of the above treatments, Synergy(®) spinal cord (ECP) stimulator with two electrodes (Quad PISCES(©) ) placed at the level of T9-T10. Results. There has been a reduction in pain of about 80% and an improvement of intermittent claudication (one of the patients no longer claudicates, whereas the other patient claudicates at 400 m). Conclusion. Neurostimulation of the posterior funiculi could be considered not only as palliative care but also as a therapeutic option.