COVID-19 pandemic and the consumption of self-care products for pediculosis capitis in Portugal: an interrupted time-series analysis.

This study aims to assess the effect of the COVID-19 pandemic on the consumption of self-care products for pediculosis capitis management, in Portugal. A segmented regression analysis of interrupted time series (March 2020) was performed from January 2017 to August 2023 to analyze the short- and long-term impact of the COVID-19 pandemic on the consumption of pediculicides and related products. Monthly rates of absolute consumption were estimated by community pharmacies' dispensing records. Portuguese municipalities were organized into quintiles according to their purchasing power index and percentage of youth, to study the association of these social and demographic variables on the sale of these products. COVID-19 pandemic significantly reduced the sales of products indicated for pediculosis. Since the start of the pandemic, an absolute decrease of 21.0 thousand packages was observed in the monthly average consumption (p < 0.0001) compared to the pre-pandemic period. After this reduction, the average monthly trend increased in the pandemic period in comparison with the previous period, although not significant (267.0 packages per month, p = 0.1102). Regions with higher disposable income and more young people were associated with higher sales of these products. The outbreak of the COVID-19 pandemic has had a notable impact on the sales of self-care products for pediculosis capitis in Portugal, in the short term. The lockdowns and other isolation measures implemented to control the spread of the virus may have led to a decrease in the number of head lice cases, consequently resulting in a reduction in sales of products.

Frameworks, Dimensions, Definitions of Aspects, and Assessment Methods for the Appraisal of Quality of Health Data for Secondary Use: Comprehensive Overview of Reviews.

BACKGROUND: Health care has not reached the full potential of the secondary use of health data because of-among other issues-concerns about the quality of the data being used. The shift toward digital health has led to an increase in the volume of health data. However, this increase in quantity has not been matched by a proportional improvement in the quality of health data. OBJECTIVE: This review aims to offer a comprehensive overview of the existing frameworks for data quality dimensions and assessment methods for the secondary use of health data. In addition, it aims to consolidate the results into a unified framework. METHODS: A review of reviews was conducted including reviews describing frameworks of data quality dimensions and their assessment methods, specifically from a secondary use perspective. Reviews were excluded if they were not related to the health care ecosystem, lacked relevant information related to our research objective, and were published in languages other than English. RESULTS: A total of 22 reviews were included, comprising 22 frameworks, with 23 different terms for dimensions, and 62 definitions of dimensions. All dimensions were mapped toward the data quality framework of the European Institute for Innovation through Health Data. In total, 8 reviews mentioned 38 different assessment methods, pertaining to 31 definitions of the dimensions. CONCLUSIONS: The findings in this review revealed a lack of consensus in the literature regarding the terminology, definitions, and assessment methods for data quality dimensions. This creates ambiguity and difficulties in developing specific assessment methods. This study goes a step further by assigning all observed definitions to a consolidated framework of 9 data quality dimensions.

Identification of Drugs Acting as Perpetrators in Common Drug Interactions in a Cohort of Geriatric Patients from Southern Italy and Analysis of the Gene Polymorphisms That Affect Their Interacting Potential.

BACKGROUND: Pharmacogenomic factors affect the susceptibility to drug-drug interactions (DDI). We identified drug interaction perpetrators among the drugs prescribed to a cohort of 290 older adults and analysed the prevalence of gene polymorphisms that can increase their interacting potential. We also pinpointed clinical decision support systems (CDSSs) that incorporate pharmacogenomic factors in DDI risk evaluation. METHODS: Perpetrator drugs were identified using the Drug Interactions Flockhart Table, the DRUGBANK website, and the Mayo Clinic Pharmacogenomics Association Table. Allelic variants affecting their activity were identified with the PharmVar, PharmGKB, dbSNP, ensembl and 1000 genome databases. RESULTS: Amiodarone, amlodipine, atorvastatin, digoxin, esomperazole, omeprazole, pantoprazole, simvastatin and rosuvastatin were perpetrator drugs prescribed to >5% of our patients. Few allelic variants affecting their perpetrator activity showed a prevalence >2% in the European population: CYP3A4/5*22, *1G, *3, CYP2C9*2 and *3, CYP2C19*17 and *2, CYP2D6*4, *41, *5, *10 and *9 and SLC1B1*15 and *5. Few commercial CDSS include pharmacogenomic factors in DDI-risk evaluation and none of them was designed for use in older adults. CONCLUSIONS: We provided a list of the allelic variants influencing the activity of drug perpetrators in older adults which should be included in pharmacogenomics-oriented CDSSs to be used in geriatric medicine.

Alignment of two standard terminologies for dosage form: RxNorm from the National Library of Medicine for the United States and EDQM from the European Directorate for the Quality in Medicines and Healthcare for Europe.

BACKGROUND: There is currently no system that aligns pharmaceutically equivalent medicinal products across nations, creating obstacles to transnational medication prescribing and medical research. EDQM has been internationally recognized as the leading system in systematic pharmaceutical product descriptions. RxNorm is a critical terminology based in the US and used widely in applications internationally that would benefit from alignment with EDQM-based dosage form descriptions. GOAL: Demonstrate a method for alignment of RxNorm dosage forms with EDQM terminologies and with EDQM dosage forms. Describe obstacles and advantages of such an alignment for ultimate application in calculating universal Pharmaceutical Product Identifiers. METHODS: A pharmaceutical sciences student and a clinical pharmacology expert in dosage forms used definitions supplied by RxNorm and EDQM technical documentation to align the 120 RxNorm dose forms to EDQM-based dosage form description terms. The alignment of RxNorm to EDQM was then used to fit the RxNorm dose forms into an ontology based on EDQM. RESULTS AND CONCLUSIONS: The alignment of RxNorm and EDQM requires further validation but provides a potential method of establishing interoperability between the two terminologies without cumbersome manual reclassification. There remain ambiguities within each dosage form nomenclature that create obstacles to integrating medication databases rooted in EDQM and RxNorm into a single worldwide database.

Effects of a theory-based advance care planning intervention for nursing homes: A cluster randomized controlled trial.

BACKGROUND: Uptake of advance care planning in routine nursing home care is low. Through extensive literature review, theoretical development, and stakeholder involvement, we developed the ACP+ intervention. AIMS: To evaluate the effects of ACP+ on the knowledge and self-efficacy (confidence in own skills) of nursing home care staff concerning advance care planning. DESIGN: Cluster randomized controlled trial, conducted between February 2018 and January 2019 (NCT03521206, clinicaltrials.gov). ACP+ is a multicomponent intervention aimed at training and supporting nursing home staff and management in implementing advance care planning in nursing home practice through a train-the-trainer approach over 8 months. Fourteen nursing homes were randomized using a matched-pairing strategy, seven received ACP+, seven followed usual practice. Analyses (intention-to-treat) involved linear mixed models. SETTING/PARTICIPANTS: Nursing homes in Flanders (Belgium). RESULTS: 694 of 1017 care staff (68% response rate) at baseline and 491 of 989 care staff (50%) post-intervention (8 months) returned questionnaires. Post-intervention, care staff's self-efficacy concerning advance care planning was significantly higher in the intervention than in the control group (baseline-adjusted mean difference 0.57; 95% CI 0.20-0.94; p = 0.003; Cohen's d = 0.30). Advance care planning knowledge (95% CI 0.95-1.15; p = 0.339; ratio: 1.04) did not differ significantly between groups. CONCLUSIONS: The ACP+ intervention for nursing homes improved care staff's self-efficacy but not their knowledge concerning advance care planning. Considering the comprehensive and multi-component approach used, these effects were smaller than expected. Reasons for this may be related to the chosen follow-up period, outcomes and measurements, or to the intervention itself and its implementation.

Aggregations of Substance in Virtual Drug Models Based on ISO/CEN Standards for Identification of Medicinal Products (IDMP).

In this study representation of chemical substances in IDMP is reviewed, with an exploration of aggregation levels for substance used in the virtual drug data models of RxNorm, SNOMED-CT, ATC/INN, and the Belgian SAM database, for products with a single substance and combinations of substances. Active moiety and available solid states forms are explored for diclofenac, amoxicillin, carbamazepine, amlodipine, with regard to their representation in coding systems such as WHODrug, SMS, UNII, CAS, and SNOMED-CT. By counting the number of medicinal products in Belgium for amlodipine in each level of aggregation, concepts for grouper of substances and two levels of grouper of medicinal products are illustrated. Recommendations are made for the further development of IDMP and its link to international drug classifications.

Propionyl-L-carnitine for intermittent claudication.

BACKGROUND: Peripheral arterial disease (PAD) is a manifestation of systemic atherosclerosis. Intermittent claudication is a symptomatic form of PAD that is characterized by pain in the lower limbs caused by chronic occlusive arterial disease. This pain develops in a limb during exercise and is relieved with rest. Propionyl-L-carnitine (PLC) is a drug that may alleviate the symptoms of PAD through a metabolic pathway, thereby improving exercise performance. OBJECTIVES: The objective of this review is to determine whether propionyl-L-carnitine is efficacious compared with placebo, other drugs, or other interventions used for treatment of intermittent claudication (e.g. exercise, endovascular intervention, surgery) in increasing pain-free and maximum walking distance for people with stable intermittent claudication, Fontaine stage II. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and the ClinicalTrials.gov trials register to July 7, 2021. We undertook reference checking and contact with study authors and pharmaceutical companies to identify additional unpublished and ongoing studies. SELECTION CRITERIA: Double-blind randomized controlled trials (RCTs) in people with intermittent claudication (Fontaine stage II) receiving PLC compared with placebo or another intervention. Outcomes included pain-free walking performance (initial claudication distance - ICD) and maximal walking performance (absolute claudication distance - ACD), analyzed by standardized treadmill exercise test, as well as ankle brachial index (ABI), quality of life, progression of disease, and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, extracted data, and evaluated trials for risk of bias. We contacted study authors for additional information. We resolved any disagreements by consensus. We performed fixed-effect model meta-analyses with mean differences (MDs) and 95% confidence intervals (CIs). We graded the certainty of evidence according to GRADE. MAIN RESULTS: We included 12 studies in this review with a total number of 1423 randomized participants. A majority of the included studies assessed PLC versus placebo (11 studies, 1395 participants), and one study assessed PLC versus L-carnitine (1 study, 26 participants). We identified no RCTs that assessed PLC versus any other medication, exercise, endovascular intervention, or surgery. Participants received PLC 1 grams to 2 grams orally (9 studies) or intravenously (3 studies) per day or placebo. For the comparison PLC versus placebo, there was a high level of both clinical and statistical heterogeneity due to study size, participants coming from different countries and centres, the combination of participants with and without diabetes, and use of different treadmill protocols. We found a high proportion of drug company-backed studies. The overall certainty of the evidence was moderate. For PLC compared with placebo, improvement in maximal walking performance (ACD) was greater for PLC than for placebo, with a mean difference in absolute improvement of 50.86 meters (95% CI 50.34 to 51.38; 9 studies, 1121 participants), or a 26% relative improvement (95% CI 23% to 28%). Improvement in pain-free walking distance (ICD) was also greater for PLC than for placebo, with a mean difference in absolute improvement of 32.98 meters (95% CI 32.60 to 33.37; 9 studies, 1151 participants), or a 31% relative improvement (95% CI 28% to 34%). Improvement in ABI was greater for PLC than for placebo, with a mean difference in improvement of 0.09 (95% CI 0.08 to 0.09; 4 studies, 369 participants). Quality of life improvement was greater with PLC (MD 0.06, 95% CI 0.05 to 0.07; 1 study, 126 participants). Progression of disease and adverse events including nausea, gastric intolerance, and flu-like symptoms did not differ greatly between PLC and placebo. For the comparison of PLC with L-carnitine, the certainty of evidence was low because this included a single, very small, cross-over study. Mean improvement in ACD was slightly greater for PLC compared to L-carnitine, with a mean difference in absolute improvement of 20.00 meters (95% CI 0.47 to 39.53; 1 study, 14 participants) or a 16% relative improvement (95% CI 0.4% to 31.6%). We found no evidence of a clear difference in the ICD (absolute improvement 4.00 meters, 95% CI -9.86 to 17.86; 1 study, 14 participants); or a 3% relative improvement (95% CI -7.4% to 13.4%). None of the other outcomes of this review were reported in this study. AUTHORS' CONCLUSIONS: When PLC was compared with placebo, improvement in walking distance was mild to moderate and safety profiles were similar, with moderate overall certainty of evidence. Although In clinical practice, PLC might be considered as an alternative or an adjuvant to standard treatment when such therapies are found to be contraindicated or ineffective, we found no RCT evidence comparing PLC with standard treatment to directly support such use.

Potential negative impact of reputed regulators' decisions on the approval status of new cancer drugs in Latin American countries: A descriptive analysis.

BACKGROUND: Many new cancer drugs are being approved by reputed regulatory authorities without evidence of overall survival benefit, quality of life improvement, and often based on clinical trials at high risk of bias. In recent years, most Latin American (LA) countries have reformed their marketing authorization (MA) rules to directly accept or abbreviate the approval process in case of earlier authorization by the European Medicines Agency (EMA) and the US Food and Drug Administration, mainly. This study assessed the potential impact of decisions taken by EMA regarding the approval of new cancer drugs based on no evidence of overall survival or in potentially biased clinical trials in LA countries. DESIGN: Descriptive analysis. SETTING: Publicly accessible marketing authorization databases from LA regulators, European Public Assessment Report by EMA, and previous studies accessing EMA approvals of new cancer drugs 2009-2016. MAIN OUTCOME AND MEASURES: Number of new cancer drugs approved by LA countries without evidence of overall survival (2009-2013), and without at least one clinical trial scored at low risk of bias, or with no trial supporting the marketing authorization at all (2014-2016). RESULTS: Argentina, Brazil, Chile, Colombia, Ecuador, Panama and Peru have publicly accessible and trustful MA databases and were included. Of the 17 cancer drugs approved by EMA (2009-2013) without evidence of OS benefit after a postmarketing median time of 5.4 years, 6 LA regulators approved more than 70% of them. Of the 13 drugs approved by EMA (2014-2016), either without supporting trial or with no trial at low risk of bias, Brazil approved 11, Chile 10, Peru 10, Argentina 10, Colombia 9, Ecuador 9, and Panama 8. CONCLUSIONS: LA countries keep approving new cancer drugs often based on poorly performed clinical trials measuring surrogate endpoints. EMA and other reputed regulators must be aware that their regulatory decisions might directly influence decisions regarding MA, health budgets and patient's care elsewhere.

Advance care planning in nursing homes: new conversation and documentation tools.

Although advance care planning (ACP) is highly relevant for nursing home residents, its uptake in nursing homes is low. To meet the need for context-specific ACP tools to support nursing home staff in conducting ACP conversations, we developed the ACP+intervention. At its core, we designed three ACP tools to aid care staff in discussing and documenting nursing home resident's wishes and preferences for future treatment and care: (1) an extensive ACP conversation guide, (2) a one-page conversation tool and (3) an ACP document to record outcomes of conversations. These nursing home-specific ACP tools aim to avoid a purely document-driven or 'tick-box' approach to the ACP process and to involve residents, including those living with dementia according to their capacity, their families and healthcare professionals.

Differences in advance care planning among nursing home care staff.

BACKGROUND: A team-based approach has been advocated for advance care planning in nursing homes. While nurses are often put forward to take the lead, it is not clear to what extent other professions could be involved as well. OBJECTIVES: To examine to what extent engagement in advance care planning practices (e.g. conversations, advance directives), knowledge and self-efficacy differ between nurses, care assistants and allied care staff in nursing homes. DESIGN: Survey study. PARTICIPANTS/SETTING: The study involved a purposive sample of 14 nursing homes in Flanders, Belgium. Nurses, care assistants and allied care staff (e.g. social workers, physical therapists) completed a survey. ETHICAL CONSIDERATIONS: The study was approved by the University Hospital of Brussels (B.U.N. 143201834759), as part of a cluster randomized controlled trial (clinicaltrials.gov NCT03521206). RESULTS: One hundred ninety-six nurses, 319 care assistants and 169 allied staff participated (67% response rate). After adjusting for confounders, nurses were significantly more likely than care assistants to have carried out advance care planning conversations (odds ratio 4; 95% confidence interval 1.73-9.82; p < 0.001) and documented advance care planning (odds ratio 2.67; 95% confidence interval 1.29-5.56; p < 0.001); differences not found between allied staff and care assistants. Advance care planning knowledge total scores differed significantly, with nurses (estimated mean difference 0.13 (score range 0-1); 95% confidence interval 0.08-0.17; p < 0.001) and allied staff (estimated mean difference 0.07; 95% confidence interval 0.03-0.12; p < 0.001) scoring higher than care assistants. We found no significant differences regarding self-efficacy. DISCUSSION: While nursing home nurses conducted more advance care planning conversations and documentation than allied care staff and care assistants, these two professional groups may be a valuable support to nurses in conducting advance care planning, if provided with additional training. CONCLUSIONS: Allied care staff and care assistants, if trained appropriately, can be involved more strongly in advance care planning to enhance relational and individual autonomy of nursing home residents, alongside nurses. Future research to improve and implement advance care planning should consider this finding at the intervention development stage.

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries.

OBJECTIVE: To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. METHODS: Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. RESULTS: Regulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. CONCLUSIONS: Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

Efficacy, feasibility and acceptability of the OptiMEDs tool for multidisciplinary medication review in nursing homes.

AIM(S): Exploring efficacy, feasibility and acceptability of a complex multifaced intervention (OptiMEDs) supporting multidisciplinary medication reviews in Belgian nursing homes (NHs). METHODS: A pilot study in 2 intervention, 1 control NH was held, involving dementia and non-dementia NH residents (>65 years). OptiMEDs provided automated assessment of possible inappropriate medications (PIMs) and patient-specific nurse observation lists of potential side-effects. Medication changes were evaluated one month after the medication review. Feasibility and acceptability was collected via surveys among the health-care professionals. Trial registration NCT04142645, 31/10/2019. RESULTS: Participants (n = 148, n = 100 in the intervention NHs) had a mean age of 87.2 years, with 75.0% females and 49.3% non-dementia patients. Prevalence of PIM use was 84.7% and of potential medication side-effects 84.5%, (range 1-19 per resident). One month after the intervention, the medication use decreased in 35.8% and PIM use in 25.9% of surviving intervention NHresidents (n = 88). GPs changed more medications when side-effects were observed (42% when side-effects present versus 12% when no side-effects, p = 0.019). Median workload for nurses was 45 min, 20 for pharmacists, and 8 for GPs. User satisfaction for the OptiMEDs tool was high (n = 33, median score of 8, IQR 6 -8), with GPs (n = 19) showing the highest appreciation. Nurses (n = 9) reported a median score on the System Usability Scale of 70 (IQR 55 - 72), with lower scores for learnability aspects. CONCLUSION: The OptiMEDs intervention was feasible and user-friendly, showing decreases in the medication and PIM use; without affecting patient safety. A cluster-randomized trial is needed to explore impact on patient-related outcomes.

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries

[ABSTRACT]. Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries’ regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators’ websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

[RESUMEN]. Objetivo. Describir el estado actual de la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones en América Latina y el Caribe mediante la evaluación de los marcos regulatorios nacionales para la aprobación de nuevos medicamentos y establecer los organismos regulatorios extranjeros que se consideran autoridades regulatorias confiables para cada país. Métodos. Se realizaron búsquedas en los sitios web de las autoridades regulatorias de América Latina y el Caribe para identificar las regulaciones oficiales para la aprobación de nuevos medicamentos. La recopilación de datos se llevó a cabo en diciembre del 2019 y se completó en junio del 2020 para los países del Caribe. Dos equipos independientes recopilaron información sobre el reconocimiento directo o los procedimientos abreviados para la aprobación de nuevos medicamentos y los autoridades regulatorias de referencia (confiables) así definidos en la legislación nacional correspondiente. Resultados. Se encontraron documentos regulatorios sobre la aprobación de nuevos productos en los sitios web de veinte organismos regulatorios de América Latina y el Caribe, que abarcaban 34 países. Siete países no aceptan la utilización de decisiones de autoridades regulatorias extranjeras. Trece autoridades regulatorias (Argentina, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, México, Panamá, Paraguay, Perú, República Dominicana, Uruguay y el sistema regulador único para quince Estados del Caribe) aceptan de manera explícita confiar las decisiones para aprobación de nuevos medicamentos emitidas por la Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá. Diez países aceptan también utilizar las autorizaciones para la comercialización de Australia, Japón y Suiza. Argentina, Brasil, Chile y México son autoridades de referencia para ocho autoridades regulatorias en la región. Conclusiones. La utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se han convertido en una práctica común en América Latina y el Caribe. Trece de veinte autoridades regulatorias reconocen directamente o abrevian el proceso de aprobación de nuevos medicamentos en caso de que hayan recibido previamente la aprobación por parte de un organismo regulatorio de otra jurisdicción. La Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá son las autoridades regulatorias de otras jurisdicciones en las cuales los reguladores de América Latina y el Caribe confían más.

[RESUMO]. Objetivo. Descrever a prática atual de uso de decisões regulatórias de outras jurisdições na América Latina e no Caribe (ALC) mediante avaliação os marcos regulatórios dos países para aprovação de novos medicamentos e verificar, para cada país, quais entidades reguladoras estrangeiras são consideradas autoridades reguladoras de confiança por cada país. Métodos. Foi realizada uma pesquisa nos sites das autoridades reguladoras da ALC para identificar as regulamentações oficiais para aprovação de novos medicamentos. A coleta de dados foi feita em dezembro de 2019 e concluída em junho de 2020 para os países do Caribe. Dois grupos independentes coletaram informações sobre o reconhecimento direto ou o procedimento abreviado para aprovação de novos medicamentos e as autoridades reguladoras de referência (de confiança) definidas como tal pela respectiva legislação nacional. Resultados. Documentos regulatórios relacionados à aprovação de novos produtos foram obtidos de 20 sites de órgãos reguladores da ALC, abrangendo 34 países. Sete países não admitem o uso de decisões regulatórias de entidades reguladoras externas. Treze autoridades reguladoras (na Argentina, Colômbia, Costa Rica, El Salvador, Equador, Guatemala, México, Panamá, Paraguai, Peru, República Dominicana, Uruguai e o Sistema Regulador do Caribe unificado para 15 Estados caribenhos) admitem explicitamente a admissibilidade de decisões regulatórias para aprovação de novos medicamentos de outras jurisdições, quais sejam: Agência Europeia de Medicamentos (EMA), Agência Reguladora de Alimentos e Medicamentos (FDA) dos EUA e Health Canada. Dez países também aceitam decisões para autorização de comercialização da Austrália, Japão e Suíça. Argentina, Brasil, Chile e México são autoridades de referência para oito agências reguladoras. Conclusões. O uso de decisões regulatórias de outras jurisdições tornou-se prática comum na América Latina e Caribe. Treze das 20 agências reguladoras reconhecem diretamente ou abreviam o procedimento de aprovação de novos medicamentos no caso de tal aprovação já haver sido concedida por uma autoridade reguladora de outra jurisdição. A EMA, a FDA e a Health Canada são as autoridades estrangeiras nas quais as agências reguladoras da América Latina e Caribe mais confiam.

International recommendations for an effective control of head louse infestations.

Head louse infestations continue to be a concern of public health in most countries, including the most developed ones. The present recommendations are intended to inform and stress the role and impact of the different authorities, institutions, industry, and the public in the control of head lice in order to reduce the prevalence of this parasite. We encourage health authorities to pursue more effective methods to correctly identify such infestations, and evaluate existing and new pediculicides, medical devices, louse repellents, and louse- and nit-removal remedies. Pediculicides and medical devices must have verifiable claims in the instructions for use and should be tested periodically to document current levels of resistance by lice to the active ingredients and to the formulated products. Where the prevalence of lice is claimed to be epidemic, children should be periodically evaluated objectively to document the actual level of prevalence. Continuing education for health providers and the general population promises to correct misinformation regarding the biology, prevention, and management of lice. Parents should regularly inspect their children for head lice and treat as necessary. Health authorities are encouraged to eliminate policies and practices that rely upon school exclusion as a means to reduce incidence and prevalence, e.g., the 'no-nit' policy which lacks scientific justification, and are counterproductive to the health and welfare of children.

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries / Utilización de decisiones de autoridades regulatorias de otras jurisdicciones para aprobar nuevos productos medicinales en países de América Latina y el Caribe / Uso de decisões regulatórias de outras jurisdições para aprovação de novas especialidades farmacêuticas em países da América Latina e Caribe

ABSTRACT Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

RESUMEN Objetivo. Describir el estado actual de la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones en América Latina y el Caribe mediante la evaluación de los marcos regulatorios nacionales para la aprobación de nuevos medicamentos y establecer los organismos regulatorios extranjeros que se consideran autoridades regulatorias confiables para cada país. Métodos. Se realizaron búsquedas en los sitios web de las autoridades regulatorias de América Latina y el Caribe para identificar las regulaciones oficiales para la aprobación de nuevos medicamentos. La recopilación de datos se llevó a cabo en diciembre del 2019 y se completó en junio del 2020 para los países del Caribe. Dos equipos independientes recopilaron información sobre el reconocimiento directo o los procedimientos abreviados para la aprobación de nuevos medicamentos y los autoridades regulatorias de referencia (confiables) así definidos en la legislación nacional correspondiente. Resultados. Se encontraron documentos regulatorios sobre la aprobación de nuevos productos en los sitios web de veinte organismos regulatorios de América Latina y el Caribe, que abarcaban 34 países. Siete países no aceptan la utilización de decisiones de autoridades regulatorias extranjeras. Trece autoridades regulatorias (Argentina, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, México, Panamá, Paraguay, Perú, República Dominicana, Uruguay y el sistema regulador único para quince Estados del Caribe) aceptan de manera explícita confiar las decisiones para aprobación de nuevos medicamentos emitidas por la Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá. Diez países aceptan también utilizar las autorizaciones para la comercialización de Australia, Japón y Suiza. Argentina, Brasil, Chile y México son autoridades de referencia para ocho autoridades regulatorias en la región. Conclusiones. La utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se han convertido en una práctica común en América Latina y el Caribe. Trece de veinte autoridades regulatorias reconocen directamente o abrevian el proceso de aprobación de nuevos medicamentos en caso de que hayan recibido previamente la aprobación por parte de un organismo regulatorio de otra jurisdicción. La Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá son las autoridades regulatorias de otras jurisdicciones en las cuales los reguladores de América Latina y el Caribe confían más.

RESUMO Objetivo. Descrever a prática atual de uso de decisões regulatórias de outras jurisdições na América Latina e no Caribe (ALC) mediante avaliação os marcos regulatórios dos países para aprovação de novos medicamentos e verificar, para cada país, quais entidades reguladoras estrangeiras são consideradas autoridades reguladoras de confiança por cada país. Métodos. Foi realizada uma pesquisa nos sites das autoridades reguladoras da ALC para identificar as regulamentações oficiais para aprovação de novos medicamentos. A coleta de dados foi feita em dezembro de 2019 e concluída em junho de 2020 para os países do Caribe. Dois grupos independentes coletaram informações sobre o reconhecimento direto ou o procedimento abreviado para aprovação de novos medicamentos e as autoridades reguladoras de referência (de confiança) definidas como tal pela respectiva legislação nacional. Resultados. Documentos regulatórios relacionados à aprovação de novos produtos foram obtidos de 20 sites de órgãos reguladores da ALC, abrangendo 34 países. Sete países não admitem o uso de decisões regulatórias de entidades reguladoras externas. Treze autoridades reguladoras (na Argentina, Colômbia, Costa Rica, El Salvador, Equador, Guatemala, México, Panamá, Paraguai, Peru, República Dominicana, Uruguai e o Sistema Regulador do Caribe unificado para 15 Estados caribenhos) admitem explicitamente a admissibilidade de decisões regulatórias para aprovação de novos medicamentos de outras jurisdições, quais sejam: Agência Europeia de Medicamentos (EMA), Agência Reguladora de Alimentos e Medicamentos (FDA) dos EUA e Health Canada. Dez países também aceitam decisões para autorização de comercialização da Austrália, Japão e Suíça. Argentina, Brasil, Chile e México são autoridades de referência para oito agências reguladoras. Conclusões. O uso de decisões regulatórias de outras jurisdições tornou-se prática comum na América Latina e Caribe. Treze das 20 agências reguladoras reconhecem diretamente ou abreviam o procedimento de aprovação de novos medicamentos no caso de tal aprovação já haver sido concedida por uma autoridade reguladora de outra jurisdição. A EMA, a FDA e a Health Canada são as autoridades estrangeiras nas quais as agências reguladoras da América Latina e Caribe mais confiam.

'Advance care planning, general practitioners and patients: a phase II cluster-randomised controlled trial in chronic life-limiting illness'.

OBJECTIVES: Although general practice is an ideal setting for ensuring timely initiation of advance care planning (ACP) in people with chronic life-limiting illness, evidence on the effectiveness of ACP in general practice and how it can be implemented is lacking. This study aims to evaluate feasibility and acceptability of study procedures and intervention components of an intervention to facilitate the initiation of ACP in general practice for people with chronic life-limiting illness. METHODS: Pilot cluster-randomised controlled trial testing a complex ACP intervention in general practice versus usual care (ClinicalTrials.gov: NCT02775032). We used a mixed methods approach using detailed documentation of the recruitment process, questionnaires and semi-structured interviews. RESULTS: A total of 25 general practitioners (GPs) and 38 patients were enrolled in the study. The intervention was acceptable to GPs and patients, with GPs valuing the interactive training and patients finding ACP conversations useful. However, we found a number of challenges regarding feasibility of recruitment procedures, such GP as recruitment proceeding more slowly than anticipated as well as difficulty applying the inclusion criteria for patients. Some GPs found initiating ACP conversations difficult. The content of the patient booklet was determined to potentially be too complex for patients with a lower health literacy. CONCLUSION: Although the intervention was well-accepted by GPs and patients, we identified critical points for improvement with regard to the study procedures as well as potential improvements of the intervention components. When these points are addressed, the intervention can proceed to a large-scale, phase III trial to test its effectiveness.

Coding Systems for Clinical Decision Support: Theoretical and Real-World Comparative Analysis.

BACKGROUND: Effective clinical decision support systems require accurate translation of practice recommendations into machine-readable artifacts; developing code sets that represent clinical concepts are an important step in this process. Many clinical coding systems are currently used in electronic health records, and it is unclear whether all of these systems are capable of efficiently representing the clinical concepts required in executing clinical decision support systems. OBJECTIVE: The aim of this study was to evaluate which clinical coding systems are capable of efficiently representing clinical concepts that are necessary for translating artifacts into executable code for clinical decision support systems. METHODS: Two methods were used to evaluate a set of clinical coding systems. In a theoretical approach, we extracted all the clinical concepts from 3 preventive care recommendations and constructed a series of code sets containing codes from a single clinical coding system. In a practical approach using data from a real-world setting, we studied the content of 1890 code sets used in an internationally available clinical decision support system and compared the usage of various clinical coding systems. RESULTS: SNOMED CT and ICD-10 (International Classification of Diseases, Tenth Revision) proved to be the most accurate clinical coding systems for most concepts in our theoretical evaluation. In our practical evaluation, we found that International Classification of Diseases (Tenth Revision) was most often used to construct code sets. Some coding systems were very accurate in representing specific types of clinical concepts, for example, LOINC (Logical Observation Identifiers Names and Codes) for investigation results and ATC (Anatomical Therapeutic Chemical Classification) for drugs. CONCLUSIONS: No single coding system seems to fulfill all the needs for representing clinical concepts for clinical decision support systems. Comprehensiveness of the coding systems seems to be offset by complexity and forms a barrier to usability for code set construction. Clinical vocabularies mapped to multiple clinical coding systems could facilitate clinical code set construction.

Guiding principles for the use of knowledge bases and real-world data in clinical decision support systems: report by an international expert workshop at Karolinska Institutet.

INTRODUCTION: Technical and logical breakthroughs have provided new opportunities in medicine to use knowledge bases and large-scale clinical data (real-world) at point-of-care as part of a learning healthcare system to diminish the knowledge-practice gap. AREAS COVERED: The article is based on presentations, discussions and recommendations from an international scientific workshop. Value, research needs and funding avenues of knowledge bases and access to real-world data as well as transparency and incorporation of patient perspectives are discussed. EXPERT OPINION: Evidence-based, publicly funded, well-structured and curated knowledge bases are of global importance. They ought to be considered as a public responsibility requiring transparency and handling of conflicts of interest. Information has to be made accessible for clinical decision support systems (CDSS) for healthcare staff and patients. Access to rich and real-world data is essential for a learning health care ecosystem and can be augmented by data on patient-reported outcomes and preferences. This field can progress by the establishment of an international policy group for developing a best practice guideline on the development, maintenance, governance, evaluation principles and financing of open-source knowledge bases and handling of real-world data.

Nurses' self-efficacy, rather than their knowledge, is associated with their engagement in advance care planning in nursing homes: A survey study.

BACKGROUND: Considering social cognitive theory and current literature about successful advance care planning in nursing homes, sufficient knowledge and self-efficacy are important preconditions for staff to be able to carry out advance care planning in practice. AIM: Exploring to what extent nurses' knowledge about and self-efficacy is associated with their engagement in advance care planning in nursing homes. DESIGN: Survey study as part of a baseline measurement of a randomised controlled cluster trial (NCT03521206). SETTING/PARTICIPANTS: Nurses in a purposive sample of 14 nursing homes in Belgium. METHODS: A survey was distributed among nurses, evaluating knowledge (11 true/false items), self-efficacy (12 roles and tasks on 10-point Likert-type scale) and six advance care planning practices (yes/no), ranging from performing advance care planning conversations to completing advance directives. RESULTS: A total of 196 nurses participated (66% response rate). While knowledge was not significantly associated with advance care planning practices, self-efficacy was. One unit's increase in self-efficacy was statistically associated with an estimated 32% increase in the number of practices having carried out. CONCLUSIONS: Nurses' engagement in advance care planning practices is mainly associated with their self-efficacy rather than their knowledge. Further research is necessary to improve the evidence regarding the causal relationship between constructs. However, these results suggest that educational programmes that focus solely on knowledge might not lead to increasing uptake of advance care planning in nurses.