Implementation of a traceability system and safe manufacturing medications in a clean room. / Implantación de un sistema de trazabilidad y elaboración segura de medicamentos en la sala blanca.

OBJECTIVE: To describe the process of implementing a traceability and safe drug manufacturing system in the clean room of a Pharmacy Service to increase patient safety, in accordance with current legislation. METHODS: The process was carried out between September 2021 and July 2022. The software program integrated all the recommended stages of the manufacturing process outlined in the "Good Practices Guide for Medication Preparation in Pharmacy Services" (GBPP). The following sections were parameterized in the software program: personnel, facilities, equipment, starting materials, packaging materials, standardized work procedures, and quality controls. RESULTS: A total of 50 users, 4 elaboration areas and 113 equipments were included. 435 components were parameterized (195 raw materials and 240 pharmaceutical specialties), 54 packaging materials, 376 standardized work procedures (123 of them corresponding to sterile medicines and 253 to non-sterile medicines, of which 52 non-sterile were dangerous), in addition 17 were high risk, 327 medium risk, 32 low risk, and 13 quality controls. CONCLUSIONS: The computerization of the production process has allowed the implementation of a traceability and secure drug manufacturing system in a controlled environment in accordance with current legislation.

Medication reconciliation on admission in paediatric chronic patients: A multicentre study.

INTRODUCTION: Medication reconciliation (MC) is one of the main strategies to reduce medication errors in care transitions. In Spain, several guidelines have been published with recommendations for the implementation and development of MC aimed at the adult population, although paediatric patients are not included. In 2018, a study was carried out that led to the subsequent publication of a document with criteria for selecting paediatric patients in whom CM should be prioritised. OBJECTIVES: To describe the characteristics of paediatric patients most likely to suffer from errors of reconciliation (EC), to confirm whether the results of a previous study can be extrapolated. METHODOLOGY: Prospective, multicentre study of paediatric inpatients. We analysed the CE detected during the performance of the CM on admission. The best possible pharmacotherapeutic history of the patient was obtained using different sources of information and confirmed by an interview with the patient/caregiver. RESULTS: 1043 discrepancies were detected, 544 were identified as CD, affecting 317 patients (43%). Omission of a drug was the most common error (51%). The majority of CD were associated with drugs in groups A (31%), N (23%) and R (11%) of the ATC classification. Polymedication and onco-haematological based disease were the risk factors associated with the presence of CD with statistical significance. CONCLUSIONS: The findings of this study allow prioritisation of CM in a specific group of paediatric patients, favouring the efficiency of the process. Onco-haematological patients and polymedication are confirmed as the main risk factors for the appearance of CD in the paediatric population.

[Translated article] Medication reconciliation in pediatric hemato-oncologic patients: A multicenter study.

OBJECTIVE: To determine the prevalence of reconciliation errors on admission to hospital in the pediatric onco-hematological population in order to check whether they are similarly susceptible to these reconciliation errors as adults and to describe the characteristics of the patients who suffer them. METHODS: A 12-month prospective, multicentre study of medication reconciliation on admission in the pediatric onco-hematological population to assess the incidence of reconciliation errors and to describe the characteristics of the patients. RESULTS: Medication reconciliation was performed in 157 patients. At least a medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were related to patient's new clinical situation or by the physician, while 48.9% were determined to be reconciliation errors. The most frequent type of reconciliation error was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a reconciliation error. CONCLUSIONS: In order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic pediatric patients, such as onco-hematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication reconciliation errors on admission to hospital, and the omission of some medication was the main cause of these errors.

Multicentre study of medication reconciliation in paediatric onco-hematology. / Estudio multicéntrico de conciliación de la medicación en onco-hematología pediátrica.

OBJECTIVE: To determine the prevalence of reconciliation errors (RE) on admission to hospital in the paediatric onco-haematological population in order to check whether they are similarly susceptible to these RE as adults and to describe the characteristics of the patients who suffer them. METHODS: A 12-month prospective, multicentre study of medication reconciliation on admission in the paediatric onco-haematological population to assess the incidence of RE and describe the characteristics of the patients in whom they occur. RESULTS: Medication reconciliation was performed in 157 patients. At least 1 medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were justified by the patient's new clinical situation or by the physician, while 48.9% were determined to be RE. The most frequent type of RE was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a RE. CONCLUSIONS: In order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic paediatric patients, such as onco-haematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication RE on admission to hospital, with the omission of some medication being the main cause of these errors.

Criteria for the selection of paediatric patients susceptible to reconciliation error.

OBJECTIVES: Many medication errors occur during care transitions, which are critical points for patient safety. There is strong evidence in favour of medication reconciliation as a strategy to avoid errors in adults, though few studies have been made in the paediatric setting. Likewise, no recommendations have been established for the selection and/or prioritisation of paediatric patients amenable to reconciliation. METHODS: A retrospective study was conducted involving patients subjected to reconciliation by a pharmacist on admission to hospital and who experienced at least one reconciliation error between January and November 2018. Univariable and multivariable analyses were performed to identify possible factors associated with reconciliation error, using a logistic regression model to determine the odds ratio (OR) with the corresponding 95% confidence interval (95% CI). RESULTS: The group of patients with at least one reconciliation error included 334 patients, compared with the group of patients without reconciliation errors, which included 1426 patients. It was determined that schoolchildren and adolescent patients had a risk of presenting a reconciliation error on hospital admission that was more than double for younger patients (OR 2.32, 95% CI 1.26 to 4.25, and OR 2.68, 95% CI 1.44 to 4.99, respectively). This risk was multiplied by five if we compared polymedicated patients versus non-polymedicated patients (OR 4.48, 95% CI 3.35 to 5.99). Patients with a neurological or onco-haematological underlying disease had a 12 and 10 times higher risk of presenting a reconciliation error compared with patients with other types of underlying diseases (OR 11.97, 95% CI 7.57 to 18.92, and OR 9.96, 95% CI 6.09 to 16.28, respectively). Finally, patients with narrow therapeutic index medicines in their usual treatment had an almost three times greater risk of presenting a reconciliation error when admitted to the hospital, although this last factor was not determined as an independent risk factor as for the others (OR 2.98, 95% CI 2.22 to 3.99). CONCLUSIONS: The paediatric population is characterised by a number of risk factors for reconciliation error. Knowledge of these factors can allow the prioritisation of medication reconciliation in a concrete group of patients. In order to generalise the results obtained in this study, they must be confirmed in other paediatric care settings involving larger samples and different types of patients.

Use of carglumic acid in valproate-induced hyperammonemia: 25 pediatric cases.

Hyperammonemic encephalopathy is a rare but potentially dangerous complication of the antiepileptic drug (AED) sodium valproate (VPA). We report a retrospective study of 25 pediatric patients, (15 females [60%]; age: 7.6 ± 4.9 years), with different underlying disorders, who suffered from hyperammonemia due to VPA and who were treated with carglumic acid (CA). The duration of treatment with VPA was 15 ± 1 month, with a dose of 40 ± 16.6 mg/kg/d. VPA blood levels were 75.5 ± 60 mg/L with seven patients being overdosed (>100 mg/L). Twenty-three patients received concomitant treatment with other AEDs. The initial dose of CA was 100 mg/kg. Subsequently, CA doses of 25 mg/kg were given to 22 patients every 6 hours (average treatment length 2.17 ± 1.1 days) until ammonemia was normalized. In nine patients, CA was used in combination with other drugs to treat hyperammonemia. In all cases, blood ammonia levels were brought under control and symptoms of hyperammonemia resolved. Two hours after CA administration, the average reduction in ammonium levels was 53 ± 29 and 88.6 ± 47.5 µmol/L at 24 hours, resulting in a statistically significant decrease when compared to pretreatment levels. There were no statistically significant differences between sexes, in the presence or not of cognitive impairment or previous carnitine treatment. There were no statistically significant differences when comparing treatment with CA plus ammonia scavengers vs CA alone. In 17 patients (68%) VPA was discontinued and 62% of the patients who maintained treatment had recurrent episodes of hyperammonemia.

Off-Label and Unlicensed Drugs in Pediatric Palliative Care: A Prospective Observational Study.

CONTEXT: Off-label and unlicensed use of drugs is a widespread practice in pediatric care because of the lack of specific efficacy and safety data and the absence of formulations adapted to the needs of these individuals. Pediatric patients with a life-limiting illness frequently receive drugs under these conditions, although no studies have established the prevalence of this practice. OBJECTIVES: To describe the prevalence, indications, and most common uses of off-label and unlicensed drugs in a pediatric palliative care unit (PPCU). METHODS: A prospective cross-sectional observational study carried out between January and October 2019. RESULTS: About 85 patients involving 1198 prescriptions were analyzed. A total of 39.6% were off label, and 12.9% were unlicensed. All received at least one off-label drug, with a median of five per patient (interquartile range 3-7), and 81.2% received at least one unlicensed drug. A total of 36.1% of the prescriptions were considered off label because of indication, 33.8% because of dosage, and 26.6% because of age. The main drugs used off label were oral morphine, oral levetiracetam, inhaled albuterol, sublingual ondansetron, oral tizanidine, sublingual fentanyl, and oral diazepam. The main symptoms treated with off-label drugs were dyspnea, pain, and nausea/vomiting. CONCLUSION: More than half of the prescriptions in this PPCU were off label or unlicensed. Treatment indication was one of the main reasons for off-label use. Administration of compounded preparations was common in patients with a life-limiting illness.

Medication reconciliation upon admission in paediatric hospital setting: preliminary data.

Background The benefits of medication reconciliation are well established in adult patients, but not in paediatric patients, being a population not included in the guidelines for medication reconciliation published so far. However, it is known that a significant number of children suffer from chronic illnesses leading to a complex pharmacological treatment. Moreover, there are a series of specific factors that cause a greater risk of medication errors in children. Aim The purpose of the present study was to determine whether patients from a paediatric hospital setting may benefit from medication reconciliation at hospital admission, in order to prevent and reduce prescribing errors on admission. Main outcome measures The primary outcome was the number of discrepancies between best possible medication history and prescribed treatment upon admission and, consequently, number of reconciliation errors. The secondary outcome was the main underlying disease with the highest number of reconciliation errors, and the main pharmacotherapeutic groups involved. Results The pharmacist reconciled the medication of 187 patients with an mean age of 6.6 ± 5.1 years. Sixty percent of patients had a base disease and 12.3% had polypharmacy, with an average of 6 drugs per patient. In a 42% of patients, at least one discrepancy was detected between their home treatment and the prescribed treatment upon admission, with 15% of patients having at least one reconciliation error (68% omissions). Neurological diseases were the main underlying disease with at least one reconciliation error (50%). The main pharmacotherapeutic groups involved in reconciliation errors were psychoanaleptic and psycholeptic, anti-acids, antiepileptic, and obstructive airway pharmacotherapy; each accounting for a 17.1%, 14.7%, 11.8% and 11.8% of the total, respectively. Conclusion Within our sample of paediatric patients, the rate of medication discrepancy and reconciliation errors at hospital admission was as relevant in terms of pharmacotherapy as has been reported in adults. The most frequent type of errors was omission of some home treatments. The main underlying disease with at least one error was neurological. As a whole, the detection of reconciliation errors in paediatrics by provision of medication reconciliation could be effective in reducing medication errors.

Pediatric parenteral nutrition: clinical practice guidelines from the Spanish Society of Parenteral and Enteral Nutrition (SENPE), the Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition (SEGHNP) and the Spanish Society of Hospital Pharmacy (SEFH) / Guía de práctica clínica SENPE/SEGHNP/SEFH sobre nutrición parenteral pediátrica.

Introduction:Parenteral nutrition (PN) in childhood is a treatment whose characteristics are highly variable depending on the age and pathology of the patient. Material and methods: The Standardization and Protocols Group of the Spanish Society for Parenteral and Enteral Nutrition (SENPE) is an interdisciplinary group formed by members of the SENPE, the Spanish Society of Gastroenterology, Hepatology and Pediatric Nutrition (SEGHNP) and the Spanish Society of Hospital Pharmacy (SEFH) that intends to update this issue. For this, a detailed review of the literature has been carried out, looking for the evidences that allow us to elaborate a Clinical Practice Guide following the criteria of the Oxford Center for Evidence-Based Medicine. Results: This manuscript summarizes the recommendations regarding indications, access routes, requirements, modifi cations in special situations, components of the mixtures, prescription and standardization, preparation, administration, monitoring, complications and home NP. The complete document is published as a monographic number. Conclusions: This guide is intended to support the prescription of pediatric PN. It provides the basis for rational decisions in the context of the existing evidence. No guidelines can take into account all of the often compelling individual clinical circumstances.

Introducción: la nutrición parenteral (NP) en la infancia es un tratamiento cuyas características son muy variables en función de la edad y la patología que presente el paciente. Material y métodos: el grupo de Estandarización y Protocolos de la Sociedad Española de Nutrición Parenteral y Enteral (SENPE) es un grupo interdisciplinar formado por miembros de la SENPE, Sociedad Española de Gastroenterología, Hepatología y Nutrición Pediátrica (SEGHNP) y Sociedad Española de Farmacia Hospitalaria (SEFH) que pretende poner al día este tema. Para ello, se ha realizado una revisión pormenorizada de la literatura buscando las evidencias que nos permiten elaborar una Guía de Práctica Clínica siguiendo los criterios del Oxford Centre for Evidence-Based Medicine. Resultados: este manuscrito expone de forma resumida las recomendaciones en cuanto a indicaciones, vías de acceso, requerimientos, modificaciones en situaciones especiales, componentes de las mezclas, prescripción y estandarización, preparación, administración, monitorización, complicaciones y NP domiciliaria. El documento completo se publica como número monográfico. Conclusiones: esta guía pretende servir de apoyo para la prescripción de la NP pediátrica. Constituye la base para tomar decisiones en el contexto de la evidencia existente. Ninguna guía puede tener en cuenta todas las circunstancias clínicas individuales