Study objective: Our goal is to review the outcomes of acute hypertensive/hypotensive episodes from articles published in the past 10 years that assessed the short- and long-term impact of acute hypertensive/hypotensive episodes in the perioperative setting. Methods: We conducted a systematic peer review based upon PROSPERO and Cochrane Handbook protocols. The following study characteristics were collected: study type, author, year, population, sample size, their definition of acute hypertension, hypotension or other measures, and outcomes (probabilities, odds ratio, hazard ratio, and relative risk) and the p-values; and they were classified according to the type of surgery (cardiac and non-cardiac). Results: A total of 3,680 articles were identified, and 66 articles fulfilled the criteria for data extraction. For the perioperative setting, the number of articles varies by outcome: 20 mortality, 16 renal outcomes, 6 stroke, 7 delirium and 34 other outcomes. Hypotension was reported to be associated with mortality (OR 1.02–20.826) as well as changes from the patient’s baseline blood pressure (BP) (OR 1.02–1.36); hypotension also had a role in the development of acute kidney injury (AKI) (OR 1.03–14.11). Postsurgical delirium was found in relation with BP lability (OR 1.018–1.038) and intra- and postsurgical hypotension (OR 1.05–1.22), and hypertension (OR 1.44–2.34). Increased OR (37.67) of intracranial hemorrhage was associated to postsurgical systolic BP >130 mmHg. There was a wide range of additional diverse outcomes related to hypo-, hypertension and BP lability. Conclusions: The perioperative management of BP influences short- and long-term effects of surgical procedures in cardiac and non-cardiac interventions; these findings support the burden of BP fluctuations in this setting.

Patient Support Programs (PSPs) reinforce patients’ care provided by health care professionals with the aim to improve adherence and patient empowerment. PSPs may include interventions such as home-based care, individualized medication counseling, support, training, and home delivery of medicines and/or devices. This study described these services and its impact on patient-reported outcomes and health care savings. We conducted an integrative literature review which was limited to publications from the last 10 years (2009-2019) and focused on diseases that require special support and/or parenteral administration. From 7040 total citations, we identified 64 home-based care services performed worldwide. Among the home-based care services, most were provided by nurses (n = 47/64; 73.4%) and addressed to cancer patients (n = 22/64; 34.4%); 23 out of 64 services (35.9%) incorporated telepharmacy. In general, home-based services and PSPs showed a positive impact on patients’ adherence to medication, patient satisfaction, and health-related quality of life. In addition, 14 (21.9%) services reported economic results, most of which showed that home therapy led to substantial cost savings.

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.) and the antiplatelet medication Brilinta® (ticagrelor) (AstraZeneca LP). Revision of the initiatives that are currently applied to prevent potential LASA errors in different countries around the world and debate about the emerging strategies that could be implemented in short and mid-term. At present, a common policy worldwide on the authorization of unique names for innovative medicines does not exist. The implication of authorities in topdown strategies and the importance of developing an international health policy on the authorization of unique names for innovative medicines are highlighted in the following piece of opinion.Conclusions: Building and sustaining a culture of patient safety should be considered as a global top-down strategy which involved all the elements in the system (regulatory bodies, manufacturers and suppliers). The precedent established by the FDA in prevention strategies to identify and avoid LASA errors has been extremely important and should lead to international discussion. Coordinated international efforts are urgently needed in this area for the sake of patients’ safety.

Background: There are limited data in the literature on the indirect costs associated with skin and soft tissue infections (SSTIs) in the pediatric population. This study aimed to conduct a systematic review of the indirect costs associated with SSTIs in children. Methods: The search was conducted in PubMed, SCOPUS, and Web of Science up to January 2020. Thirteen search strategies were designed combining MeSH terms and free terms. SSTIs were defined as bacterial or viral infections, dermatomycoses, and parasitic infestations. Only primary studies were included. All analyzed costs were converted to 2020 Euros. Results: Thirteen of the identified publications presented indirect costs of SSTIs in children and were conducted in Argentina, Australia, Brazil, Hungary, New Zealand, Poland, Spain, Taiwan, and the USA. Nine studies described indirect costs associated with infection of Varicella-zoster virus: lost workdays by outpatient caregivers ranged from 0.27 to 7.8, and up to 6.14 if caring for inpatients; total productivity losses ranged from €1.16 to €257.46 per patient. Three studies reported indirect costs associated with acute bacterial SSTIs (community-associated methicillin-resistant Staphylococcus aureus) in children: total productivity losses ranged from €1,814.39 to €8,224.06 per patient, based on impetigo, cellulitis, and folliculitis. One study of parasitic infestations (Pediculus humanus capitis) reported total indirect costs per patient of €68.57 (formal care) plus €21.41 due to time lost by parents in purchasing treatment. Conclusions: The economic burden of SSTIs is highly relevant but underestimated due to the lack of studies reporting indirect costs. Further cost studies will allow a better understanding of the magnitude of the financial burden of the disease.

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. All drug prescriptions in this age group were analysed and classified according to their labelling in off‐label or on‐label. The drugs prescribed off‐label were subsequently reviewed in national formularies and other databases to assess its evidence of use beyond what is recommended in the Summary of Product Characteristics (SmPC).Results: On average 34.50% of total prescriptions were prescribed off‐label according to the SmPC. 17.93% of total prescriptions in neonates and infants up to 1 year old were not based on clinical evidence from SmPC, Pediamécum, BNF or DailyMed. In more than 88% of cases, off‐label use was related to the posology section of the SmPC, followed by the therapeutic indications and contraindications sections, in 35.20% and 24.10% of cases, respectively. Almost 13% of off‐label drugs were over‐the‐counter. Salbutamol followed by topical tobramycin and colecalciferol were the drugs most prescribed off‐label.Conclusions: Off‐label use of drugs remains as an important public health concern, especially for neonates and infants up to 1 year, who receive the greatest proportion of off‐label prescriptions. The evidence‐based off‐label prescription is a widespread practice that has shown a stable trend during the 5‐year study period providing also a certain extent of flexibility to paediatricians in some therapeutic decisions.

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. Four cross-sectional annual periods, one before and the three latest periods after the adoption of the Regulation, were compared. Prescriptions in the primary health care setting were sorted by age group and drug and off-label status were determined. The number of off-label prescriptions issued by paediatricians was over two million per year. Prior to the adoption of the Paediatric Regulation, the off-label prescription rate was estimated at 7% of total prescriptions. Although the increase in the off-label rate over the study periods was mild, it was statistically significant (OR: 1.045; 95% CI: 1.043–1.046; p < 0.05). One of the most vulnerable population groups was neonates and infants up to 1 year, in which the off-label prescription rates showed the highest increase during the post follow-up period, which was statistically significant (OR: 4.270; 95% CI: 4.253–4.287; p < 0.05). The findings can help raise awareness and advocate for the development and authorization of medicines for children in the primary health care setting.