Off-label drug use in neonates and infants in Spain: A five-year observational study.

Objectives: To provide information about the off-label rate of all drug prescriptions in neonates and infants up to 1 year in Spain. Also, to analyse the off-label prescription of medicines under current practice in this age group according to different evidence sources.

Study Design: A five-year (2015-2019) exploratory observational study about off-label prescription in neonates and infants (0 to 1 year) at primary health care in Spain.

Effects of the Off-Label Drug Prescription in the Paediatric Population in Spain from the Adoption of the Latest European Regulation: A Pre-Post Study.

The year 2021 marks the 15th anniversary of the Paediatric Regulation (1901/2006/EC) in Europe. The main aim of the study was to conduct a pre-post comparison on the annual off-label prescription rates in the under-18 population in Spain and assess the potential influence of the Paediatric Regulation adoption. An observational study in the paediatric population was performed.

Prevention strategies to identify LASA errors: building and sustaining a culture of patient safety.

Background: Potential look-alike, sound-alike (LASA) errors in outpatient and inpatient prescriptions have been widely described worldwide. However, most strategies of reducing drug name confusion have been only focused on the processes of prescribing and dispensing, often following local rules.

Main Text: An illustrative recent example about this topic is given: the antidepressant Brintellix® (vortioxetine) (Takeda Pharmaceuticals USA, Inc.

Adverse Drug Events in Patients with Dementia and Neuropsychiatric/Behavioral, and Psychological Symptoms, a One-Year Prospective Study.

Older people usually present with adverse drug events (ADEs) with nonspecific symptoms such as cognitive decline, recurrent falls, reduced mobility, and/or major deterioration. The aims of this study were to assess the ADEs of patients with dementia and presenting neuropsychiatric/behavioral, and psychological symptoms in dementia (BPSD) and to categorize and identify the principal factors that allow to prevent ADEs, and separately ADEs that result in falls. To that end, a one-year prospective study in a psychogeriatric ward (July 2015 to July 2016) was performed.

Readability assessment of package leaflets of biosimilars.

Objectives: To assess the degree of readability and the length of the package leaflets of biosimilars.

Setting: The package leaflets analysed were downloaded from the European Medicines Agency (EMA) website.

Participants: The study sample included the package leaflets written in English of all the biosimilars that were authorised by the EMA on 31 August 2017, and whose content was available via the internet on that date (n=35).

Current evidence in the stability of medicines in dose administration aids: implications for patient safety.

Introduction: As the elderly population and polypharmacy are increasing, it is predicted that interventions to enhance medication adherence, as dose administration aids (DAA), will grow. One of the limitations of repackaging medicines into DAA is to assure the stability of medicines, and, therefore, their quality, efficacy and safety.

Areas Covered: This article collects and summarises data of all the stability studies of repackaged medicines into DAAs.

Assessing the stability of lamotrigine dispersible/chewable tablets when stored in blister punch cards.

Objectives: To determine the stability of lamotrigine dispersible/chewable tablets (DCTs) when stored in blister punch cards (BPCs).

Methods: Lamotrigine 100 mg DCTs were randomly repackaged into a US Pharmacopeia Class A 1 week cold-sealed BPC. Chemical and physical stability were evaluated over a 60 day period, in controlled conditions corresponding to Climatic Zones I/II (25 °C ± 2 °C; 60% ± 5% relative humidity).

Readability Analysis of the Package Leaflets for Biological Medicines Available on the Internet Between 2007 and 2013: An Analytical Longitudinal Study.

Background: The package leaflet included in the packaging of all medicinal products plays an important role in the transmission of medicine-related information to patients. Therefore, in 2009, the European Commission published readability guidelines to try to ensure that the information contained in the package leaflet is understood by patients.

Objective: The main objective of this study was to calculate and compare the readability levels and length (number of words) of the package leaflets for biological medicines in 2007, 2010, and 2013.

Stability of enalapril repackaged into monitored dosage system.

A monitored dosage system (MDS) is a professionally prepared blister-type repackaging system used to improve medication adherence. The objective of this study was to determine the stability of enalapril tablets, a widely prescribed drug, commonly used by the elderly but potentially unstable in MDSs. No degradation of enalapril tablets repackaged into MDSs was observed during the 60 day study period.

Is the pharmacokinetics of bupivacaine equivalent after lumbar epidural administration through a needle or a catheter in male and female adults?

We assessed possible pharmacokinetic modifications due to different epidural injection techniques using either a needle or a catheter. Adult patients (n=23) undergoing lower abdominal or lower extremity surgery were randomly assigned a single bupivacaine epidural injection anesthesia (0.5%, 15 mL, 0.

Evaluation of electronic prescription implementation in polymedicated users of Catalonia, Spain: a population-based longitudinal study.

Objectives: To assess whether electronic prescribing is a comprehensive health management tool that may contribute to rational drug use, particularly in polymedicated patients receiving 16 or more medications in the public healthcare system in the Barcelona Health Region (BHR).

Design: 16 months of retrospective study followed by 12 months of prospective monitoring.

Setting: Primary healthcare in BHR, Catalonia, Spain.

Readability assessment of package inserts of biological medicinal products from the European medicines agency website.

Background: Package inserts that accompany medicines are a common source of information aimed at patients and should match patient abilities in terms of readability.

Objective: Our objective was to determine the degree of readability of the package inserts for biological medicinal products commercially available in 2007 and compare them with the readability of the same package inserts in 2010.

Methods: A total of 33 package inserts were selected and classified into five groups according to the type of medicine: monoclonal antibody-based products, cytokines, therapeutic enzymes, recombinant blood factors and other blood-related products, and recombinant hormones.

Profile, cost and pattern of prescriptions for polymedicated patients in Catalonia, Spain.

Objectives: Polypharmacy is one of the main management issues in public health policies because of its financial impact and the increasing number of people involved. The polymedicated population according to their demographic and therapeutic profile and the cost for the public healthcare system were characterised.

Design: Cross-sectional study.

Returned medicines in community pharmacies of Barcelona, Spain.

Objective: To monitor the amount of unused drugs and the cost to the public health system. Setting A random sample of community pharmacies in Barcelona, Spain. Method The drugs were collected from 38 community pharmacies over a period of 7 consecutive working days (excluding Sundays).

Identifying how age and gender influence prescription drug use in a primary health care environment in Catalonia, Spain.

Unlabelled: What is already known about this subject. Knowledge of prescription patterns in primary health care is an important tool in rational drug therapy. Age and gender are the principal determining factors of cost variability between medical practices, due to drug prescriptions.

Determination of saquinavir and ritonavir in human plasma by reversed-phase high-performance liquid chromatography and the analytical error function.

Two simple and reproducible high-performance liquid chromatography methods with ultraviolet detection were developed and validated for the quantitation of two protease inhibitors, saquinavir and ritonavir, in human plasma. The same single liquid-liquid extraction procedure with ethyl acetate-hexane (50:50, v/v), reversed-phase column and mobile phase were used. The analyses were accomplished using a Luna C(18) column (150 mm x 4.

Determination of abacavir in human plasma by high-performance liquid chromatography with ultraviolet detection and the analytical error function.

A rapid and simple high-performance liquid chromatography method has been developed for the determination of the HIV-1 reverse transcriptase inhibitor abacavir in human plasma. It included a single liquid-liquid extraction procedure with a mixture of ethyl acetate-diethyl ether prior to reversed-phase chromatography on a C18 column and C18 precolumn insert. Ultraviolet detection was set at 285 nm.

Self-assembly of drug-polymer complexes: a spontaneous nanoencapsulation process monitored by atomic force microscopy.

Since hydrophilic matrices were proposed for controlled drug delivery, many polymeric excipients have been studied to make drug release fit the desired profiles. It has been pointed out that lambda-carrageenan, a sulfated polymer from algae, can suitably control the release rate of basic drugs from hydrophilic matrices. Furthermore, the relevance of hydrophobic interactions in drug-polymer aqueous systems has already been demonstrated, although no references to morphological features as well as to the kinetics of the interaction complexes formation have been published to date.

Development, validation and analytical error function of two chromatographic methods with fluorimetric detection for the determination of bisoprolol and metoprolol in human plasma.

This work describes two high-performance liquid chromatographic methods for the individual determination of bisoprolol and metoprolol in human plasma. Analytical methods involve two different liquid-liquid extractions of human plasma, with diethyl ether for bisoprolol and with dichloromethane for metoprolol, coupled with a similar Nucleosil C(18) reversed-phase HPLC column. Fluorimetric detection was used to identify both beta-blockers.